INTERSEPTRecalls & reported problems across all models

We found 6 models of INTERSEPT by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2019 and Sep 18, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 reports).

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

INTERSEPT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 3, 2018Terminated

   Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.

   Z-0535-2018 · Root cause: Component change control · Recall details · FDA record ↗

2. Feb 4, 2016Terminated

   Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack.

   Z-1023-2016 · Root cause: Component design/selection · names 2 of these models · Recall details · FDA record ↗

Most reported INTERSEPT problems

INTERSEPT models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• INTERSEPT® 2D25R6

  TUBING, PUMP, CARDIOPULMONARY BYPASS
  1 recall0 reports
• INTERSEPT® 2R88R3

  TUBING, PUMP, CARDIOPULMONARY BYPASS
  1 recall0 reports
• INTERSEPT® 6T40R6

  TUBING, PUMP, CARDIOPULMONARY BYPASS
  1 recall0 reports
• Intersept® 6031

  TUBING, PUMP, CARDIOPULMONARY BYPASS
  3 reports
• Intersept® XA6061

  TUBING, PUMP, CARDIOPULMONARY BYPASS
  1 report
• Intersept® 3608

  TUBING, PUMP, CARDIOPULMONARY BYPASS
  1 report

Recent INTERSEPT adverse event reports

The 5 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Material Puncture/Hole

  Medtronic received information that during use of a PORT & PLUG, it was reported that the connector was placed into the Extra Corporeal Membrane Oxygenation (ECMO) circuit a week ago. A crack/cut on the connector which looked dark was noticed as the customer changed the circuit. Customer decided to not replace it as the patient has had many circuit changes and the crack did not go to the end of the connector so they felt that the integrity was not compromised. It was not noticed straight away either, it not until the following morning when the customer inspected the circuit. There was no adverse patient effect associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50815776 ↗
• InjuryMar 18, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. SURGICAL INTERVENTION TOOK PLACE AROUND 2008 TO 2009 WHEREIN THE IPG WAS EXPLANTED. THE LEADS WERE LEFT IMPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18923890 ↗
• 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 ↗

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