NA CB9Q53RRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169946026), received between Sep 21, 2023 and Nov 1, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

10 other recalls cover devices cleared under the same FDA submission (K891687); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT UPON PRIMING, THIS COMPONENT WAS FOUND TO BE LEAKING ALTHOUGH THE COMPONENT WAS ZIP TIED AND SOLVENT BONDED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEAK WAS ONLY SEEN IN ONE PACK. THE LEAK ORIGINATED FROM THE TUBING CONNECTION. THERE WAS NO VISIBLE AIR IN THE SYSTEM/TUBING. THE EXACT LOCATION OF THE LEAK WAS FROM THE CONNECTION BETWEEN THE MALE PERFUSION ADAPTER AND TUBING. MEDTRONIC RECEIVED FOUR DEVICES IN THE PRODUCT ANALYSIS LAB AND DURING ANALYSIS IT WAS OBSERVED THAT THERE WAS A LEAK IN ALL FOUR DEVICES WITH LITTLE TO NO BACKPRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046501 ↗
• MalfunctionNov 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT UPON PRIMING, THIS COMPONENT WAS FOUND TO BE LEAKING ALTHOUGH THE COMPONENT WAS ZIP TIED AND SOLVENT BONDED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEAK WAS ONLY SEEN IN ONE PACK. THE LEAK ORIGINATED FROM THE TUBING CONNECTION. THERE WAS NO VISIBLE AIR IN THE SYSTEM/TUBING. THE EXACT LOCATION OF THE LEAK WAS FROM THE CONNECTION BETWEEN THE MALE PERFUSION ADAPTER AND TUBING. MEDTRONIC RECEIVED FOUR DEVICES IN THE PRODUCT ANALYSIS LAB AND DURING ANALYSIS IT WAS OBSERVED THAT THERE WAS A LEAK IN ALL FOUR DEVICES WITH LITTLE TO NO BACKPRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046436 ↗
• MalfunctionNov 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT UPON PRIMING, THIS COMPONENT WAS FOUND TO BE LEAKING ALTHOUGH THE COMPONENT WAS ZIP TIED AND SOLVENT BONDED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEAK WAS ONLY SEEN IN ONE PACK. THE LEAK ORIGINATED FROM THE TUBING CONNECTION. THERE WAS NO VISIBLE AIR IN THE SYSTEM/TUBING. THE EXACT LOCATION OF THE LEAK WAS FROM THE CONNECTION BETWEEN THE MALE PERFUSION ADAPTER AND TUBING. MEDTRONIC RECEIVED FOUR DEVICES IN THE PRODUCT ANALYSIS LAB AND DURING ANALYSIS IT WAS OBSERVED THAT THERE WAS A LEAK IN ALL FOUR DEVICES WITH LITTLE TO NO BACKPRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046416 ↗
• MalfunctionNov 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT UPON PRIMING, THIS COMPONENT WAS FOUND TO BE LEAKING ALTHOUGH THE COMPONENT WAS ZIP TIED AND SOLVENT BONDED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEAK WAS ONLY SEEN IN ONE PACK. THE LEAK ORIGINATED FROM THE TUBING CONNECTION. THERE WAS NO VISIBLE AIR IN THE SYSTEM/TUBING. THE EXACT LOCATION OF THE LEAK WAS FROM THE CONNECTION BETWEEN THE MALE PERFUSION ADAPTER AND TUBING. MEDTRONIC RECEIVED FOUR DEVICES IN THE PRODUCT ANALYSIS LAB AND DURING ANALYSIS IT WAS OBSERVED THAT THERE WAS A LEAK IN ALL FOUR DEVICES WITH LITTLE TO NO BACKPRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046378 ↗
• MalfunctionSep 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED UPON PRIMING THIS COMPONENT WAS FOUND TO BE LEAKING ALTHOUGH THE COMPONENT WAS ZIP TIED AND SOLVENT BONDED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787275 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K891687. One submission often covers many models, so check the product and lot details in each record.

• Z-2495-2020 · Aug 8, 2018 · Terminated
  Extra corporeal circuit with bio-active surface.
• Z-1023-2016 · Feb 4, 2016 · Terminated
  Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvet
• 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-2105-2013 · Jul 17, 2013 · Terminated
  Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: Th
• 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-0813-2012 · Dec 14, 2011 · Terminated
  Custom Packs/Mexico, Medtronic Cardio-Kit, Sterilized Using Ethylene Oxide, Nonpyrogenic, Rx Only. Model # DLP6N48R3 & DLP6N48R4. Medtronic Intersept Custom Tubing Pack with T
• Z-1920-2008 · May 9, 2008 · Terminated
  Medtronic Extracorporeal Circuit with bio-active surface; Cardiopulmonary Bypass Oxygenator, Catalog Numbers: CB0B90R3, CB0L44R15, CB0X97R10, CB1V99R2, CB1Y06R14, CB1Z42R15, CB
• 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-1489-04 · Sep 15, 2004 · Terminated
  Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036.