The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1884-2021·Announced 2021-06-23

Medtronic Custom Perfusion System Recalled for Incomplete Welds

Specific lots of Medtronic's CB10W65R1 perfusion system tubing packs may have incomplete or insufficient welds that could compromise system integrity during cardiac surgery.

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 FDA Class II recall involves a high-risk cardiac surgical device with manufacturing defects (insufficient welds) that could cause system failure during critical use. No adverse events, injuries, or hospitalizations have been reported, making this a risk-of-harm scenario without reported harm.

Plain-English summary

Medtronic Perfusion Systems is recalling specific lots of the CB10W65R1 Custom Pack CH Access perfusion system tubing pack because certain units may have been manufactured with insufficient or incomplete welds. The defective welds could compromise the structural integrity of the tubing system used in cardiac surgical procedures.

The affected lot is 221332879 with a use-by date of October 5, 2022. The product was distributed nationwide in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas.

A perfusion system is used during cardiac surgery to provide life support by circulating and oxygenating blood outside the body during heart-lung bypass. If the tubing pack welds are defective, the system could fail or leak during the procedure. Healthcare facilities that received this lot should quarantine affected units immediately, verify inventory against the recalled lot number, and contact Medtronic for replacement units or further instructions.

The recalled product

Product
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiac / Perfusion System
Hazard
Affected units
1

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 00763000341022
  • Lot number 221332879
  • Use By 2022-10-05

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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