The Recall Desk
HighFDA (Devices)·Z-1872-2021·Announced 2021-06-23

Medtronic Perfusion System Tubing Packs Recalled Due to Weld Defects

Medtronic recalls specific lots of HY8M63R4 Adult ECC Custom Perfusion System tubing packs due to potentially insufficient or incomplete welds, which could affect performance during surgical procedures.

What this means for you

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 Class II FDA medical device recall involving a structural defect in tubing components used in critical surgical procedures. No illnesses or injuries have been reported, warranting a High severity classification as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medtronic Perfusion Systems has recalled specific lots of the HY8M63R4 Adult ECC Custom Perfusion System, a sterile medical device used during extracorporeal circulation (bypass) procedures. The affected product is a custom perfusion system supplied as 2 tubing packs.

The recall was issued because specific lots may have been manufactured with insufficient or incomplete welds in the tubing components. This defect could potentially affect the integrity and performance of the tubing during use.

The affected product was distributed nationwide in the United States, including the states of Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. The specific affected lot is #221058527, which has a use-by date of October 30, 2022.

Healthcare facilities and users who have received this product should stop using the affected lot immediately and contact Medtronic Perfusion Systems for instructions regarding replacement or return of the recalled product.

The recalled product

Product
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Perfusion System
Hazard
Affected units
2

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 (3)

  • GTIN 00643169921948
  • Lot #221058527
  • Use By 2022-10-30

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 →

Related recalls

Same manufacturer · Medtronic Perfusion Systems

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Same hazard · weld defect

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