Intersept® 6031Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 40613994352864), received between Nov 18, 2019 and Apr 22, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2022Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A 6031 INTERSEPT CONNECTOR, IT WAS REPORTED THE DEVICE WAS CRACKED WHEN THE CUSTOMER TOOK IT OUT OF THE PACKAGING. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT CUSTOMER IS UNABLE TO RECALL WHICH ARM OF THE Y WAS CRACKED, BUT IT WAS VISIBLE WITH THE NAKED EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14186132 ↗
• InjuryFeb 4, 2022Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 6031 INTERSEPT CONNECTOR, THE CUSTOMER REPORTED THAT THERE WAS A CRACK IN THE CONNECTOR, CAUSING AIR TO BE ENTRAINED IN THE ECMO CIRCUIT. THE AIR WAS VISIBLY ENTRAINING THROUGH THE CONNECTOR, AND THE CARDIOHELP BUBBLE DETECTOR ALARMED. THE CONNECTOR WAS BEING USED TO ADD AN ADDITIONAL LIMB TO ECMO CIRCUIT. THEY THINK THE PATIENT RECEIVED MICRO AIR EMBOLISM. THE PATIENT SUBSEQUENTLY EXPIRED. IT WAS REPORTED THAT THE DEATH WAS MULTIFACTORIAL BUT THE CUSTOMER DOESN'T ATTRIBUTE IT TO THIS INCIDENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CUSTOMER DID NOT NOTICE A CRACK IN THE DEVICE BEFORE USE.

  Patient problems: Air Embolism

  MAUDE report 13449600 ↗
• InjuryNov 18, 2019Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT ABOUT 20:00 HRS DURING THE EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) PROCEDURE, THE CUSTOMER REPORTED LEAKING FROM AROUND THE Y-CONNECTOR THAT CONNECTED THE LV VENT TO THE VENOUS DRAINAGE LINE ON THE ECMO CIRCUIT. THE CUSTOMER WAS CONCERNED THAT THE LEAK WAS EITHER DUE TO A LOOSE CONNECTION OR THAT ONE OF THE LINES WAS FRACTURED. FOLLOWING NOTIFICATION TO THE PERFUSIONIST, MD AND SURGEON, THEY INTENDED TO FIX THE ISSUE USING A ZIP TIE AND BONE WAX. HOWEVER, AROUND 21:00 HRS, THE Y-CONNECTOR THE BROKE AND THE PATIENT BEGAN TO EXSANGUINATE. FLOWS WERE LOST AND CPR WAS INITIATED. THEY THEN CLAMPED THE ECMO CANNULA, MASS TRANSFUSION PROTOCOL WAS INITIATED, PATIENT WAS INTUBATED AND A LINE WAS PLACED. THEY WERE ABLE TO REPLACE THE Y-CONNECTOR AND RE-ESTABLISH FLOW.

  Patient problems: Exsanguination

  MAUDE report 9334255 ↗

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