NA BB8B89R3Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169717985), received between Jan 18, 2023 and Jan 20, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO USE, THIS CUSTOM TUBING PACK HAD DAMAGED PACKAGING, INCLUDING THE OUTER PACKAGING, INNER PACKAGING, AND STERILE BARRIER. THE DEVICE WAS NOT USED, AND NO OTHER DEVICES IN THE SAME BOX OR SHIPPING CONTAINER WERE DAMAGED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116605 ↗
• MalfunctionJan 20, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE CUSTOMER REPORTED DAMAGE TO OUTSIDE SHIPPING BOX AND THERE WAS ALSO A LARGE HOLE PUNCHED THROUGH THE STERILE TYVEK COVER INSIDE THE SHIPPING BOX. THE CUSTOMER STATED THAT THE CONTENTS WERE NOT CONSIDERED STERILE WITH SUCH A LARGE HOLE IN THE TYVEK LID. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24113603 ↗
• MalfunctionFeb 6, 2025Fluid/Blood Leak; Material Separation; Air/Gas in Device; Fluid/Blood Leak; Material Separation; Air/Gas in Device

  IT WAS REPORTED THAT DURING USE OF A CUSTOM TUBING PACK THERE WAS A LEAK. THE SAT/CRIT CUVETTE IN THE VENOUS LINE SEEMED TO NOT BE SOLVENT BONDED. THIS RESULTED IN A VERY SMALL AMOUNT OF AIR BEING ENTRAINED INTO THE VENOUS LINE. THE CUSTOMER SIMPLY SECURED THE LOOSE CONNECTION USING A TIE BAND AND THERE WERE NO FURTHER ISSUES AND THE AIR ENTRAINMENT STOPPED IMMEDIATELY. THE LEAK ORIGINATED FROM THE TUBING CONNECTION. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. PATIENT BLOOD LOSS DID NOT OCCUR BECAUSE OF THE LEAK. AN UNPLANNED TRANSFUSION WAS NOT REQUIRED. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21319965 ↗
• MalfunctionJul 22, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE MALE LUER PORT ON THE END OF THE PRESSURE DOME WAS CLOGGED WITH GLUE/PLASTIC. IT WAS OCCLUDED BY THIS MATERIAL. THERE WAS NO DAMAGE TO THE PACKAGING. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791382 ↗
• MalfunctionApr 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS A LEAK FROM THE TUBING CONNECTION. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE MYOTHERM ITSELF WAS NOT LEAKING. THE LEAK CAME FROM THE TUBING CONNECTED TO ONE OF THE WYE CONNECTORS. THE CUSTOMER BELIEVED THAT THE SOLVENT MAY HAVE BEEN OMITTED FROM THE TUBING CONNECTION TO THE WYE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19151300 ↗
• MalfunctionJul 3, 2023Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE DURING PRIMING OF THIS CUSTOM TUBING PACK THE CUSTOMER OBSERVED THAT A NON-VENTED CAP APPEARED TO HAVE A DEFECTIVE SMALL HOLE IN IT THAT CAUSED FLUID TO LEAK OUT DURING PRIMING. IT WAS REPLACED WITH A NON VENTED CAP WITHOUT A DEFECTIVE HOLE IN IT AND THE PRIMING WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE PATIENT EFFECTS OCCURRED. ADDITIONAL INFORMATION RECEIVED: THE CUSTOMER STATED THAT THEY HAD 3-4 PACKS FROM THE SAME LOT WITH THESE NON VENTED CAPS WITH LITTLE PIN HOLES IN THEM. THE FLUID LEAKED OUT OF THE PIN HOLES WHEN THEY PRIMED THE SYSTEM. NO AIR WAS SEEN IN THE SYSTEM. THE LEAKS FROM THE ADDITIONAL CAPS WERE SEEN ON THE SAME DATE AND THEY WERE OBSERVED PRIOR TO THE SAME PROCEDURE MENTIONED ABOVE. ALL OF THE OCCURRENCES WILL BE CAPTURE IN THIS EVENT AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17246440 ↗
• MalfunctionJan 18, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE ARTERIAL FILTER PURGE LINE EXPERIENCED A SEPARATION DISTAL TO THE ONE WAY VALVE THAT IS IN THE PURGE LINE. THE CUSTOMER QUICKLY CLAMPED THE PURGE LINE PROXIMAL TO THE TUBING SEPARATION. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THE CUSTOMER STATED THAT THERE WAS LESS THAN 50 CC OF BLOOD LOSS DUE TO THIS EVENT. THERE WAS NO ADDITIONAL PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER PACKAGING OR STERILE BARRIER). NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE DAMAGED. THERE WAS NO TRANSFUSION REQUIRED AS A RESULT OF THIS ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16193553 ↗

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