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Lower risk Medical device recall · FDA · Published February 14, 2019

Bard PowerPort isp MRI Implantable Port: Incorrect Introducer Sheath Size Recalled

Bard recalls PowerPort isp MRI implantable ports with incorrect introducer sheath size. Affected units may cause complications during procedures. Contact Bard for details.

🇺🇸 FDA recall #Z-0582-2020Medical deviceBard ›
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Recalling firmBard Peripheral Vascular Inc1625 W 3rd St Bldg 1 · Tempe, AZ 85281-2438
✎ GovInfoNow plain-language explainer

Bard is recalling PowerPort isp MRI implantable ports that were packaged with the wrong introducer sheath size. This could lead to complications during medical procedures if the port is used incorrectly. Read more at govinfonow.com/recall/69005-bard-powerport-isp-mri-implantable-port-incorrect-introducer-sheath-size.

Source Summary by GovInfoNow · govinfonow.com/recall/69005-bard-powerport-isp-mri-implantable-port-incorrect-introducer-sheath-size · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0582-2020

Cite this page

“Bard PowerPort isp MRI Implantable Port: Incorrect Introducer Sheath Size Recalled.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69005-bard-powerport-isp-mri-implantable-port-incorrect-introducer-sheath-size. Based on FDA recall #Z-0582-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0582-2020%22&limit=1).

Bard Peripheral Vascular Inc recalled the PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter due to incorrect introducer sheath size packaging, according to the FDA. The Food and Drug Administration announced this voluntary Class II recall on Feb. 14, 2019.

How to tell if you have it

  • Brand: Bard
  • Product: PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
  • UPC: 00801741027031
  • Lot Number: RECS2407

The hazard

The FDA said the hazard involves complaints that products were packaged with the incorrect introducer sheath size.

Context

GovInfoNow's records show Bard Peripheral Vascular Inc has 40 other recalls on record since Sept. 22, 2017. Other recent recalls of similar products include Bard Breast Biopsy System May Cause Procedure Interruptions (Aug. 20, 2026), Bard Peripheral Vascular Recall: Broviac Cutdown Trays with SureCuff Cuff Risk of Sterile Barrier Compromise (Dec. 12, 2025), and Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray Recall: Erroneous Safety Indicator Risk (Nov. 6, 2025).

How to tell if you have this one

Check for the product code 1808060 or device listing number D004935 on the packaging. The lot number RECS2407 is also associated with this recall.

  • Brand
    Bard
  • Product
    PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact Bard

    Reach out to Bard Peripheral Vascular Inc for specific guidance on the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide.

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: “US - Nationwide OUS - None” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 10 months after the firm started it.

1. Firm started the recall: Feb 14, 201912. FDA classified it Class II: Nov 27, 201923. Published in FDA’s Enforcement Report: Dec 4, 201932019
  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-0582-2020 (February 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0582-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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