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Use caution Medical device recall · FDA · Published August 1, 2024

Boston Scientific Wallflex Stent System Recall: Catheter Tip Detachment Risk

Boston Scientific recalls Wallflex Esophageal Stent Systems due to potential delivery catheter tip detachment. Affected models include FC ESO STENT RMV LL 18X1:103. Consumers should contact for remedy details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3271-2024Medical deviceBoston Scientific ›
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Contact the company

Recalling firmBoston Scientific Corporation100 Boston Scientific Way · Marlborough, MA 01752-1234
✎ GovInfoNow plain-language explainer

What happened, in plain English

Boston Scientific is recalling Wallflex Esophageal Stent Systems that may have a delivery catheter tip that can detach during use. This could lead to serious complications if the stent moves incorrectly in the esophagus. Read more at govinfonow.com/recall/54337-boston-scientific-wallflex-stent-system-recall-catheter-tip-detachment-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/54337-boston-scientific-wallflex-stent-system-recall-catheter-tip-detachment-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3271-2024

Cite this page

“Boston Scientific Wallflex Stent System Recall: Catheter Tip Detachment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54337-boston-scientific-wallflex-stent-system-recall-catheter-tip-detachment-risk. Based on FDA recall #Z-3271-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3271-2024%22&limit=1).

Why it’s dangerous

The delivery catheter tip may detach during stent placement or removal. If the stent moves incorrectly in the esophagus, it could cause injury or blockage.

Who’s affected

People who have a Wallflex Esophageal Stent System for esophageal strictures or fistulas. Those with medical conditions requiring stent placement are most at risk.

How to tell if you have this one

Check for the model number M00516270 with lot numbers 32837018, 32946075, 33014125, or 33218762. The product is for esophageal strictures or fistulas.

  • Brand
    Boston Scientific
  • Product
    WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System
  • Category
    Medical device
FDA recall event · 31 products

All 31 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
Recall numberProduct, codes & lotsQuantity
Z-3265-2024WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516210; GTIN: 08714729854470 Lot Numbers: 33045962, 33120912, 33137308, 33208045, 3324508779 units
Z-3266-2024WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516220; GTIN: 08714729854487 Lot Numbers: 33017652, 33213399, 33256089, 3327553166 units
Z-3267-2024WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516230; GTIN: 08714729854494 Lot Numbers: 330941742 units
Z-3268-2024WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516240; GTIN: 08714729854500 Lot Numbers: 32867087, 32980849, 33014126, 33085585, 33128875, 33208047, 33233490, 33275533146 units
Z-3269-2024WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516250; GTIN: 08714729854517 Lot Numbers: 32809368, 32846904, 32856377, 32867089, 32898068, 32908416, 32914771, 32919348, 32938992, 33058575176 units
Z-3270-2024WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516260; GTIN: 08714729854524 Lot Numbers: 32752366, 32752367, 32789716, 32919840, 32927193, 32956258, 32994874, 33056529145 units
Z-3271-2024WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516270; GTIN: 08714729905523 Lot Numbers: 32837018, 32946075, 33014125, 3321876277 units
Z-3272-2024WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516300; GTIN: 08714729905554 Lot Numbers: 32771052, 3284690540 units
Z-3273-2024WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516310; GTIN: 08714729905561 Lot Numbers: 32858862, 32865977, 32898069, 32914769, 32985474, 33256092115 units
Z-3274-2024WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516320; GTIN: 08714729905578 Lot Numbers: 32753933, 32937357, 32987960, 3321876377 units
Z-3275-2024WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516700; GTIN: 08714729778035 Lot Numbers: 32779260, 32790021, 32817917, 32860922, 32906415, 32966005, 32967262, 33026701, 33026703, 33077154, 33077157, 33085584 33147800, 33156072, 33218764, 33256093231 units
Z-3276-2024WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516710; GTIN: 08714729778042 Lot Numbers: 32779261, 32820237, 32906416, 33030432, 33077155, 33077156, 33094173, 33137309, 33137313, 33195043124 units
Z-3277-2024WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516720; GTIN: 08714729778059 Lot Numbers: 32770266, 32780362, 32865975, 32906417, 32975732, 33017656, 33128876, 3316713579 units
Z-3278-2024WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516730; GTIN: 08714729778066 Lot Numbers: 32770264, 32779262, 32799929, 32799930, 32809367, 32927194, 32946077, 32976902, 32977680, 32977681, 33017674, 33036450 33036451, 33045963, 33064554, 33064555, 33085586, 33130671, 33130672, 33195044, 33195045, 33214280, 33218599, 33266647364 units
Z-3279-2024WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516740; GTIN: 08714729778073 Lot Numbers: 32771050, 32771051, 32789719, 32790020, 32827713, 32837013, 32837014, 32846903, 32856378, 32875122, 32876614, 32888839 32906418, 32914770, 32919349, 32927196, 32928279, 32938993, 33014831, 33038108, 33101459, 33102100, 33119729, 33137310 33137311, 33137312, 33145979, 33176328, 33218760, 33256094, 33266648507 units
Z-3280-2024WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516750; GTIN: 08714729778080 Lot Numbers: 32809369, 32809370, 32820234 ,32829719, 32837015, 32859849, 32888837, 32888838, 32914768, 32919658, 32919659, 32938991 32956256, 32977683, 32980850, 32986659, 32994875, 32998177, 33014830, 33101458, 33119730, 33176329, 33195046, 33195048 33208043, 33208044, 33218761, 33242625, 33266646, 33266649516 units
Z-3281-2024WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516900; GTIN: 08714729765240 Lot Numbers: 32759902, 32780160, 32830094, 32865976, 32868557, 32875121, 32891029, 32898065, 32898066, 32906414, 32915745, 32938540 32966004, 32977682, 32985473, 33026702, 33026704, 33036452, 33036453, 33045964, 33056440, 33119731, 33120913, 33167136 33169265, 33169266, 33169267297 units
Z-3282-2024WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516910; GTIN: 08714729765257 Lot Numbers: 32780161, 32827704, 32875120, 32876612, 32915744, 32946076, 32967272, 32967273, 33014124, 33030431, 33045961, 33077152 33128873, 33146800, 33176330, 33195047, 33226266, 33233489, 33256090, 33256091308 units
Z-3283-2024WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516920; GTIN: 08714729765264 Lot Numbers: 32965060, 33077153, 33120914, 3326665039 units
Z-3284-2024WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516930; GTIN: 08714729765271 Lot Numbers: 32770265, 32799938, 32799939 32809371, 32809372, 32957301 33128874, 33156073, 33156074 33156075, 33156076, 33233491 33233492133 units
Z-3285-2024WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516940; GTIN: 08714729765288 Lot Numbers: 32759900, 32759903, 32789717 32789718, 32829629, 32847692 32848481, 32898067, 32919347 32927195, 32949480, 32956257 32957302, 32965072, 32985475 32987961, 33047928, 33145976 33145978, 33208046, 33208048 33242626, 33275535305 units
Z-3286-2024WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516950; GTIN: 08714729765295 Lot Numbers: 32764205, 32764206, 32827703 32837016, 32837017, 32850357 32869530, 32876613, 32891019 32900187, 32938379, 33145977 33160189, 33167134, 33242627199 units
Z-3287-2024AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517710; GTIN: 00191506006587 Lot Numbers: 331788436 units
Z-3288-2024AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517720; GTIN: 00191506006594 Lot Numbers: 3321532715 units
Z-3289-2024AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517730; GTIN: 00191506006600 Lot Numbers: 3300508617 units
Z-3290-2024AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517740; GTIN: 00191506006617 Lot Numbers: 3300508418 units
Z-3291-2024AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517760; GTIN: 00191506006631 Lot Numbers: 3300508518 units
Z-3292-2024AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517780; GTIN: 00191506006655 Lot Numbers: 3326665119 units
Z-3293-2024AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517790; GTIN: 00191506006662 Lot Numbers: 32889020, 331788447 units
Z-3294-2024AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517800; GTIN: 00191506006679 Lot Numbers: 3300508710 units
Z-3295-2024AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517820; GTIN: 00191506006693 Lot Numbers: 32889021, 331788456 units
Based on the official FDA remedy

What to do — step by step

  1. Contact Boston Scientific

    Reach out to Boston Scientific for specific remedy instructions as the recall record does not provide a remedy.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Aug 1, 202412. FDA classified it Class II: Sep 26, 202423. Published in FDA’s Enforcement Report: Oct 2, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3271-2024 (August 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3271-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA