The Recall Desk
HighFDA (Devices)·Z-1881-2021·Announced 2021-06-23

Medtronic Cardiac Perfusion Tubing Packs Recalled Due to Defective Welds

Medtronic is recalling specific lots of CB4W67R20 Custom Perfusion System tubing packs due to incomplete welds that could affect system performance. The recall affects 61 packs distributed across nine states.

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: FDA Class II recall affecting cardiac perfusion system tubing. This qualifies as a risk-of-harm product (used in critical cardiac surgery) where defective welds could affect system performance. No illnesses or injuries have been reported.

Plain-English summary

Medtronic Perfusion Systems is recalling specific lots of CB4W67R20 Custom Pack CB4W67R20 Adult E Custom Perfusion System sterile tubing packs due to a manufacturing defect. The recall was initiated because some tubing packs may have been manufactured with insufficient or incomplete welds.

The recall affects 61 tubing packs distributed to facilities in nine states: Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. The affected lot is 221238939, which has a use-by date of March 3, 2022.

Affected healthcare providers or patients should contact Medtronic Perfusion Systems or their healthcare provider for further instructions regarding this product. Medtronic is working with the FDA on this Class II recall.

The recalled product

Product
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiac Perfusion System
Hazard
Affected units
61

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 00763000286378
  • Lot number 221238939
  • Use By 2022-03-03

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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