The Recall Desk
HighFDA (Devices)·Z-1027-2023·Announced 2023-02-08

Temperature Monitoring Adapter Detachment in Cardiopulmonary Bypass Oxygenators

Medtronic is recalling cardiopulmonary bypass equipment because the Temperature Monitoring Adapter can come loose during setup or disassembly, potentially compromising temperature monitoring during heart 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 an FDA Class II recall involving a risk-of-harm product—the loose Temperature Monitoring Adapter could compromise critical temperature monitoring during cardiac surgery. No injuries or illnesses have been reported, which limits the score to 3 per the rubric for risk-of-harm products without reported harm.

Plain-English summary

Medtronic Perfusion Systems is recalling Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenators with Integrated Arterial Filter and Balance Biosurface (Model BB811). These devices are used during cardiopulmonary bypass procedures to provide oxygen and remove carbon dioxide from blood during heart surgery.

The recall was initiated due to an upward trend of complaints that the Temperature Monitoring Adapter (TMA), located on the oxygenator, has come loose either during pre-procedure perfusion set-up or after the procedure when disassembling the perfusion circuit. A loose adapter could compromise temperature monitoring during cardiac surgery.

The recall affects 63,278 units with worldwide distribution, including the United States and numerous international locations. Affected devices are identified by specific serial number ranges (8111483548–8113999999) and lot numbers detailed in the FDA recall notice.

Healthcare facilities should review the FDA recall notice for affected lot numbers and serial numbers, inspect potentially affected devices, and contact Medtronic Perfusion Systems for instructions on obtaining replacement adapters or devices.

The recalled product

Product
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiopulmonary Bypass Equipment
Hazard
Affected units
63,278

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 BB811
  • Serial Number Range: 8111483548 - 8113999999
  • GTIN Number
  • Tubing Pack Model Number (Lot Numbers): 00643169231948
  • M390082B (223422891
  • 223952683
  • 225651632)
  • 00643169345379
  • M961233A (223537804)
  • 00643169422025
  • M445428F (223378929
  • 223672423
  • 223909336
  • 224399508
  • 224695321
  • 225303449
  • 225434680)
  • 00643169439269
  • M274805B (223714089
  • 224907239)

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 · component detachment

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