NA CB11A09R3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000324537), received between Jun 20, 2023 and Jun 20, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE DURING PRIMING OF THIS CUSTOM TUBING PACK IT WAS NOTED THAT THE H/S CUVETTE WAS FAULTY AND LEAKED. CUSTOMER FEELS THERE IS A CRACK IN THE PLASTIC. CUVETTE WAS REMOVED AND REPLACED WITH A STAND-ALONE PIECE TO COMPLETE THE CASE AND THERE IS NO ADVERSE PATIENT EFFECT. ADDITIONAL INFORMATION: THE OTHER OCCURRENCE REPORTED FOR THE SAME LOT # HAS BEEN CAPTURED IN MPXR #771263 PE 704037137.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162781 ↗
• MalfunctionJun 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE DURING PRIMING OF THIS CUSTOM TUBING PACK IT WAS NOTED THAT THE H/S CUVETTE WAS FAULTY AND LEAKED. CUSTOMER FEELS THERE IS A CRACK IN THE PLASTIC. CUVETTE WAS REMOVED AND REPLACED WITH A STAND-ALONE PIECE TO COMPLETE THE CASE AND THERE IS NO ADVERSE PATIENT EFFECT. ADDITIONAL INFORMATION: A SECOND OCCURRENCE WAS REPORTED FOR THE SAME LOT #. THE SALES REP HAS SUBMITTED A SECOND MPXR #776020 (PE 704063965) TO CAPTURE THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162749 ↗

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.