The Recall Desk
HighFDA (Devices)·Z-1892-2021·Announced 2021-06-23

Medtronic Cardiac Perfusion Tubing Packs Recalled for Incomplete Welds

Medtronic is recalling specific lots of BB8M63R5 adult cardiac perfusion tubing packs due to incomplete welds in the manufacturing process. These defects could compromise tubing integrity during cardiac surgery.

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 device recall involving a manufacturing defect in a critical component of cardiac surgery equipment. Although no injuries or deaths have been reported in the source text, incomplete welds in perfusion tubing present substantial risk in critical surgical applications.

Plain-English summary

Medtronic Perfusion Systems is recalling specific manufacturing lots of the BB8M63R5 Custom Pack Adult ECC (Extracorporeal Circulation) tubing packs. These are sterile, prescription medical device components used in custom perfusion systems during cardiac surgery.

The recall was issued because specific manufacturing lots may have been produced with insufficient or incomplete welds. Incomplete welds could affect the integrity and reliability of the tubing during use.

The affected lot number is 221249911, with a use-by date of October 22, 2022. The product was distributed nationwide to facilities in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas.

Healthcare providers who possess the affected tubing packs should discontinue use and contact Medtronic for instructions regarding replacement or return of the recalled inventory.

The recalled product

Product
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiac Surgery Equipment
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 00763000458133
  • Lot number 221249911
  • Use By 2022-10-22

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 · incomplete welds

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