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Lower risk Medical device recall · FDA · Published April 29, 2021

Medtronic Perfusion Systems: Custom Perfusion System with Welding Risk

Medtronic recalls specific lots of Custom Perfusion Systems due to potential insufficient welds that could cause leaks. Affected units have GTIN 00763000156879 and lot number 221679870.

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

🇺🇸 FDA recall #Z-1890-2021Medical deviceMedtronic Perfusion Systems ›
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Contact the company

Recalling firmMedtronic Perfusion Systems7611 Northland Dr N · Brooklyn Park, MN 55428-1088
✎ GovInfoNow plain-language explainer

Medtronic is recalling specific lots of Custom Perfusion Systems because some units may have been manufactured with insufficient or incomplete welds. This could lead to leaks, which might cause harm to users. Read more at govinfonow.com/recall/62643-medtronic-perfusion-systems-custom-perfusion-system-with-welding-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62643-medtronic-perfusion-systems-custom-perfusion-system-with-welding-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1890-2021

Cite this page

“Medtronic Perfusion Systems: Custom Perfusion System with Welding Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62643-medtronic-perfusion-systems-custom-perfusion-system-with-welding-risk. Based on FDA recall #Z-1890-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1890-2021%22&limit=1).

The FDA announced on April 29, 2021, that Medtronic Perfusion Systems is recalling specific lots of Custom Perfusion Systems due to insufficient or incomplete welds. The agency classified the recall as Class II.

How to tell if you have it

  • Medtronic HY10L28R3
  • Custom Pack HY10L28R3 1/4 Pack
  • Custom Perfusion System, Sterile, Rx.
  • GTIN 00763000156879
  • Lot number 221679870
  • Use By 2022-12-03

The hazard

Specific lots may have been manufactured with insufficient or incomplete welds.

Context

GovInfoNow's records show Medtronic Perfusion Systems has 31 other recalls on record since June 22, 2017. Other recent recalls of similar products include Medtronic EOPA Arterial Cannula Recall (June 24, 2026), Medtronic Pediatric Cannula Recall (May 25, 2026), and Medtronic Octopus Evolution Tissue Stabilizer Model TS2000 Recall (May 12, 2026). Other recent recalls of similar products include Medline Perfusion Syringe Recall (October 27, 2025), Medtronic Harmony Catheter System Recall (May 22, 2026), and ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026).

How to tell if you have this one

Check for the GTIN 00763000156879 and lot number 221679870 on the product label. The product was sold with a use-by date of December 3, 2022.

  • Brand
    Medtronic Perfusion Systems
  • Product
    Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx
  • Category
    Medical device
FDA recall event · 25 products

All 25 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
    Terminated
  • Distribution
    US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.
Recall numberProduct, codes & lotsQuantity
Z-1871-2021Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.; GTIN 00763000292034, Lot #220866332, Use By 2022-09-296 tubing packs
Z-1872-2021Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.; GTIN 00643169921948, Lot #221058527, Use By 2022-10-302 tubing packs
Z-1873-2021Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.; GTIN 00763000258016, Lot numbers 221102356, Use By 2022-10-09; and 221672011, Use By 2022-10-2210 tubing packs
Z-1874-2021Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.; GTIN 20763000446516, Lot numbers 22128923, Use By 2022-10-31; and Lot 221815851, Use By 2023-01-1815 tubing packs
Z-1875-2021Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.; GTIN 00643169981102, Lot numbers 220866430, Use By 2022-04-03; 221102361, Use By 2202-04-03; and 221727287, Use By 2022-09-29.27 tubing packs
Z-1876-2021Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.; GTIN 00643169641228, Lot numbers 220866440, Use By 2022-07-10; and 221451579, Use By 2022-10-2410 tubing packs
Z-1877-2021Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.; GTIN 00763000314231, Lot numbers 220911913, Use By 2022-03-13; and 221249923, Use By 2022-10-0118 tubing packs
Z-1878-2021Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.; GTIN 00763000108328, Lot number 220776249, Use By 2022-07-064 tubing packs
Z-1879-2021Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.; GTIN 00763000341039, Lot number 221196140, Use By 2022-09-2415 tubing packs
Z-1880-2021Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.; GTIN 00763000235147, Lot number 221196141, Use By 2022-08-1912 tubing packs
Z-1881-2021Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.; GTIN 00763000286378, Lot number 221238939, Use By 2022-03-0361 tubing packs
Z-1882-2021Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.; GTIN 00763000341015, Lot numbers 221102372, Use By 2022-09-21; and 221672013, Use By 2022-11-0212 tubing packs
Z-1883-2021Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,; GTIN 00763000467449, Lot number 221227814, Use By 2022-08-2814 tubing packs
Z-1884-2021Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.; GTIN 00763000341022, Lot number 221332879, Use By 2022-10-051 tubing pack
Z-1885-2021Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.; GTIN 00763000306717, Lot number 221387881, Use By 2022-10-2111 tubing packs
Z-1886-2021Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.; GTIN 00763000082987, Lot number 221451509, Use By 2022-10-28.8 tubing packs
Z-1887-2021Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.; GTIN 00763000360436, Lot number 221451543, Use By 2022-10-2216 tubing packs
Z-1888-2021Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.; GTIN 00763000360443, Lot number 221542968, Use By 2022-11-065 tubing packs
Z-1889-2021Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.; GTIN 00643169640870, Lot number 221575680, Use By 2022-11-203 tubing packs
Z-1890-2021Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.; GTIN 00763000156879, Lot number 221679870, Use By 2022-12-035 tubing packs
Z-1891-2021Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.; GTIN 00763000499105, Lot numbers 221719701, Use By 2023-01-06; and 221764442, Use By 2023-01-1325 tubing packs
Z-1892-2021Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.; GTIN 00763000458133, Lot number 221249911, Use By 2022-10-222 tubing packs
Z-1893-2021Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.; GTIN 00643169984820, Lot 221148857, Use By 2022-10-1226 tubing packs
Z-1894-2021Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.; GTIN 00763000387044, Lot number 221238931, Use By 2022-10-176 tubing packs
Z-1895-2021Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.; GTIN 00643169947436, Lot number 221387901, Use By 2022-12-167 tubing sets
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the GTIN 00763000156879 and lot number 221679870 on the device packaging.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 9 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, Texas.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: Apr 29, 202112. FDA classified it Class II: Jun 16, 202123. Published in FDA’s Enforcement Report: Jun 23, 202134. FDA terminated the recall: Mar 20, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-1890-2021 (April 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1890-2021 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