The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1024-2023·Announced 2023-02-08

Affinity Fusion Oxygenator temperature monitoring adapter may loosen during cardiac surgery

The temperature monitoring adapter on Medtronic's Affinity Fusion Oxygenator may come loose during cardiopulmonary bypass procedures. The manufacturer has received multiple complaints about this issue.

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 is an FDA Class II medical device recall without reported hospitalizations or injuries. However, the product is a critical cardiac device where a loose temperature monitoring adapter represents a risk of harm during surgery. The source text does not report any actual injuries or adverse outcomes, only an upward trend of complaints about the loose adapter condition.

Plain-English summary

Medtronic Perfusion Systems is recalling the Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Model BB841), used in cardiopulmonary bypass procedures. The Temperature Monitoring Adapter (TMA) located on the oxygenator may come loose, occurring either during pre-procedure setup of the perfusion circuit or during post-procedure disassembly. The manufacturer has received an upward trend of complaints regarding this issue.

Cardiopulmonary bypass is used during cardiac surgery to oxygenate and circulate a patient's blood while the heart is undergoing repair or treatment. The temperature monitoring adapter is intended to monitor temperature during this critical procedure. When loose, it cannot reliably monitor temperature.

The recall affects 90,220 units with specific lot numbers and serial number ranges as documented by the FDA. Affected devices have been distributed worldwide, including throughout the United States and many other countries.

Healthcare facilities should discontinue use of affected oxygenators and contact Medtronic Perfusion Systems for replacement devices or additional guidance. Patients who have undergone cardiac procedures using these devices and have subsequent concerns should consult their healthcare provider.

The recalled product

Product
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiopulmonary Bypass Equipment
Hazard
Affected units
90,220

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)

  • Model BB841
  • Serial Number Range: 8111483548 - 8113999999
  • GTIN Number: 00643169354869 (Lot Numbers: 13384637
  • 13385152
  • 13385470
  • 13385745
  • 13385981
  • 13386194
  • 13386335
  • 13386747
  • 13386941
  • 13387068
  • 13387247
  • 13387298
  • 13387483
  • 13387670
  • 13387792
  • 13388008
  • 13388227
  • 13389074

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 →

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