NA BB3M00R30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169955790), received between Jan 15, 2026 and Jan 15, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

10 other recalls cover devices cleared under the same FDA submission (K800178); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 12, 2022Open, Classified

   An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.

   Z-1027-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED A DAMAGED CLAM SHELL AND ARTERIAL VENTRICULAR LOOP. THE CUSTOMER STATED THAT THE STERILITY WAS QUESTIONABLE. THE CUSTOMER REPORTED THAT THERE WAS NO DAMAGE TO THE OUTER PLASTIC HOUSING OF THE PUMP TRAY OR PACKAGING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CORNER OF THE CLAM SHELL WAS BENT IN AND OPEN TO AIR, THUS NOT CONSIDERED STERILE. THERE WERE NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER ALSO DAMAGED. THE CLAM SHELL SEAL WAS OPEN AND NOT INTACT. THE GREEN TAPES WERE INTACT IN THE SENSE THAT THEY WERE NOT RIPPED. THE ARTERIAL VENTRICULAR LOOP WAS LOCATED IN THE CLAM SHELL, BUT THE CLAM SHELL WAS BENT AND OPEN TO AIR. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE INSIDE ARTERIAL VENTRICULAR LOOP TUBING ITSELF, JUST THE OUTSIDE CLAM SHELL PLASTIC HOUSING. THE STERILITY WAS COMPROMISED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE NOTED TO THE SHIPPING BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087283 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K800178. One submission often covers many models, so check the product and lot details in each record.

• Z-2736-2015 · Aug 18, 2015 · Terminated
  MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3
• Z-1000-2014 · Jan 30, 2014 · Terminated
  Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized
• Z-2104-2013 · Jul 17, 2013 · Terminated
  Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Pr
• Z-0618-2013 · Nov 19, 2012 · Terminated
  Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the follow
• Z-0814-2012 · Dec 14, 2011 · Terminated
  Custom Packs/ Kerkrade. Contain Medtronic Venous Cannula, Sterile EO. Model #'s C330201C, C330201D, C330201E, C330206B, C342603A, C350106A, C390101D, C390203D, C390406C, C390409
• Z-1424-2009 · Feb 25, 2009 · Terminated
  Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits
• Z-1227-2007 · Aug 1, 2007 · Terminated
  Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604 USA. Diffe
• Z-0583-2007 · Jan 2, 2007 · Terminated
  Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and
• Z-0340-2007 · Sep 13, 2006 · Terminated
  Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the
• Z-0808-05 · Mar 25, 2005 · Terminated
  Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requ