NA 9J90R4Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000001346), received between Jun 16, 2022 and Jun 22, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED A SLOW LEAK IN A BONDED CONNECTION OF THE BLOOD DELIVERY LINE OF THE MYOTHERM. IT WAS A SLOW LEAK, SO THEY WERE ABLE TO FINISH THE CASE WITHOUT INCIDENT. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: THERE WAS AROUND 50CC OF PATIENT BLOOD LOSS AS A RESULT OF THIS LEAK. NO TRANSFUSION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17180823 ↗
• MalfunctionJun 21, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE CUSTOM TUBING PACK, ONCE PRIMED, THE CUSTOMER NOTICED FLUID LEAKING FROM THE WHITE LUER CAP IN THE PACK, DUE TO A SMALL HOLE IN THE CAP. THE CAP WAS SWITCHED FOR A NEW LUER CAP DURING PRIMING, PRIOR TO THE START OF THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE PATIENT EFFECTS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169271 ↗
• MalfunctionJun 9, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE CUSTOM TUBING PACK THE CUSTOMER NOTED THAT ONE OF THE TWO WHITE LUER CAPS IN LINE C ON THE CARDIOPLEGIA SET HAD A PIN PRICK HOLE IN IT THAT CAUSED LEAKING. THE CAP WAS SWITCHED FOR A NEW LUER CAP DURING PRIMING, PRIOR TO THE START OF THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE PATIENT EFFECTS OCCURRED. ADDITIONAL INFORMATION: THERE WAS NO VISIBLE AIR IN THE SYSTEM/TUBING. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097797 ↗
• MalfunctionJun 16, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, DURING PRIMING OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE LUER CAPS IN THE CUSTOM TUBING PACK HAD TINY PINPRICK HOLES WHICH SHOULD NOT BE THERE. THE CUSTOMER STATED THAT THE HOLES CAUSED VERY SLOW DRIPS OF FLUID. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14711366 ↗

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