NA CB10W63R1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000341039), received between Jul 29, 2020 and Aug 6, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Apr 29, 2021Terminated

   Specific lots may have been manufactured with insufficient or incomplete welds.

   Z-1879-2021 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• InjuryAug 6, 2020Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THE CUSTOM PACK, SEPARATION OF A SOLVENT BOND WAS NOTED AND BLOOD LEAKED FROM THE PIGTAIL CONNECTION. THE DEVICE WAS NOT REPLACED. PATIENT REQUIRED EPINEPHRINE, HOWEVER THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. SPECIALIST WAS GIVING A MEDICATION, NOTED BLOOD LEAKING FROM CONNECTION. ATTEMPTED TO DRY OFF PIGTAIL TO IDENTIFY SITE OF LEAK AND HUB DISCONNECTED FROM TUBING. EVENT WAS ON AT RUN HOUR 210. BLOOD FLOW WAS 0.55LPM AND THE PRESSURE IN THE LINE IT WAS CONNECTED TO WAS 126MMHG.

  Patient problems: Blood Loss

  MAUDE report 10372104 ↗
• InjuryJul 29, 2020Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM PACK, SEPARATION OF A SOLVENT BOND WAS NOTED. THE DEVICE WAS NOT REPLACED TO COMPLETE THE CASE. PATIENT REQUIRED ONE UNIT OF BLOOD, HOWEVER THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON JULY 16TH, 2020: RUN HOUR 135, BLOOD WAS BEING DRAWN FROM THE CUSTOM PACK PIGTAIL AND BLOOD BEGAN LEAKING FROM HUB-TUBING CONNECTION. PRESSURE IN THE LINE WAS 37MMHG AND THE BLOOD FLOW THROUGH THE LINE WAS 225ML/MIN.

  Patient problems: Blood Loss

  MAUDE report 10337787 ↗

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.