The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1877-2021·Announced 2021-06-23

Medtronic Perfusion System Tubing Packs Recalled for Weld Defects

Medtronic is recalling 18 tubing packs used in perfusion systems due to potentially incomplete or insufficient welds that may compromise device integrity. No injuries have been reported.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device with an actual manufacturing defect (incomplete welds) that could compromise device function during critical cardiac procedures. No illnesses or injuries have been reported. The FDA Class II classification combined with the absence of reported incidents places this at Score 3 per the rubric.

Plain-English summary

Medtronic Perfusion Systems is recalling specific lots of HY11B40R1 Custom Pack perfusion system tubing because the products may have been manufactured with insufficient or incomplete welds.

Eighteen tubing packs were affected. The lot numbers involved are 220911913 (Use By 2022-03-13) and 221249923 (Use By 2022-10-01). These products were distributed nationwide to healthcare facilities in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. No illnesses or injuries have been reported in connection with this recall.

Incomplete or insufficient welds in the tubing could potentially compromise the structural integrity of the perfusion system during use. Healthcare providers and facilities that have received these products should contact Medtronic Perfusion Systems to determine the appropriate course of action.

The recalled product

Product
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Perfusion System
Hazard
Affected units
18

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • GTIN 00763000314231
  • Lot numbers 220911913
  • Use By 2022-03-13
  • and 221249923
  • Use By 2022-10-01

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 25 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 25 products in this recall →

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