NA BB8B73R7Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000001377), received between Jun 12, 2023 and Jun 12, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

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.

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.

• MalfunctionJun 12, 2023Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE DEVICE LEAKED WHILE PRIMING. THE PRE-BYPASS FILTER WAS FOUND TO HAVE A LEAK IN THE SEAL AND WAS ALLOWING SOME AIR TO BE ENTRAINED. EACH TIME THE CUSTOMER DEAIRED IT, AIR WOULD ENTER THROUGH THE FILTER AGAIN. IT DID NOT IMPACT THE PROCEDURE OR CASE AT ALL. THE DEVICE WAS REPLACED PRIOR TO INITIATION OF BYPASS. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEAK IS ALONG THE SEAL OF THE ACTUAL FILTER. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO PATIENT BLOOD LOSS. NO TRANSFUSION WAS REQUIRED AS A RESULT OF THE LEAK. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT NO LEVEL OF SUCTION OR VENTING WAS USED, THE PRE-BYPASS FILTER (PBF) IS ONLY USED DURING PRIMING AND THEN IS REMOVED. A BUBBLE DETECTOR OR BUBBLE COUNTER WAS NOT USED. THE PBF IS ONLY USED DURING PRIMING. IT IS LOCATED IN THE VENOUS LINE SO ANY AIR THAT WOULD HAVE BEEN ENTRAINED BECAUSE OF THE LEAK WOULD HAVE BEEN PURGED INTO THE VENOUS LINE AND INTO THE OPEN RESERVOIR. IT WOULD NOT PASS THROUGH THE CIRCUIT. THE PURGE LINE WAS OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106337 ↗

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