The Recall Desk
HighFDA (Devices)·Z-1028-2023·Announced 2023-02-08

Medtronic Perfusion Oxygenator Temperature Monitoring Adapter Detachment Recall

Medtronic has recalled Custom Pack Perfusion Tubing Packs used in cardiopulmonary bypass procedures. The Temperature Monitoring Adapter on the oxygenator may detach during setup or disassembly.

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 medical device with a documented hazard (Temperature Monitoring Adapter detachment) that poses a risk of harm in critical cardiopulmonary bypass procedures. However, no injuries, hospitalizations, or deaths are reported in the source text, placing this in the risk-of-harm category where injury has not yet been reported.

Plain-English summary

Medtronic Perfusion Systems has recalled Custom Pack Perfusion Tubing Packs containing the Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (REF CB811). These packs are used in cardiopulmonary bypass procedures to support heart and lung function during open-heart surgery.

An upward trend of complaints has been reported in which the Temperature Monitoring Adapter (TMA) becomes loose from the oxygenator. This can occur either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.

The recall involves 40,498 units distributed worldwide, including the United States and numerous countries throughout Europe, Asia, Africa, and the Americas.

The recalled product

Product
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiopulmonary Bypass Equipment
Hazard
Affected units
40,498

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 (20)

  • Oxygenator Model CB811
  • Serial Number Range: 8111483548 - 8113999999
  • GTIN Number
  • Tubing Pack Model Number (Lot Numbers): 00643169505322
  • HY2Q32R9 (223366543
  • 224282023)
  • 00643169572263
  • HY8L55R5 (222887140
  • 223145744
  • 223145745
  • 223283258
  • 223323300
  • 223685612
  • 223685613
  • 223685614
  • 223860888
  • 223860889
  • 224043160
  • 224327270
  • 224327271

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Related recalls

Same manufacturer · Medtronic Perfusion Systems

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Same hazard · device detachment

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