Intersept Custom Tubing PackRecalls & reported problems across all models

We found 2 models of Intersept Custom Tubing Pack by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Sep 12, 2023 and Dec 1, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (2 reports).

1 FDA recall record 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 Custom Tubing Pack 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. 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 · Recall details · FDA record ↗

Most reported Intersept Custom Tubing Pack problems

Intersept Custom Tubing Pack models

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

• Intersept® Custom Tubing Pack 1N16R19

  PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
  1 recall0 reports
• Intersept® Custom Tubing Pack 9156R2

  Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
  3 reports

Recent Intersept Custom Tubing Pack adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A MEDTRONIC OVERPRESSURE RELIEF VALVE, IT WAS REPORTED THAT THE DEVICE APPEARED TO FUNCTION NORMALLY FOR THE FIRST 10 MINUTES OF USE, HOWEVER, AFTER THIS PERIOD OF TIME BLOOD BEGAN TO LEAK OUT OF THE SIDE OF THE VALVE. THE LEAKAGE LARGELY OCCURRED WHEN THE VENT WAS OFF. THE USE OF THE DEVICE WAS UNSPECIFIED. IT WAS UNKNOWN IF THERE WAS ANY ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23679145 ↗
• MalfunctionOct 3, 2023Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A MEDTRONIC OVERPRESSURE RELIEF VALVE, IT WAS REPORTED THAT THE VALVE DID NOT PERFORM TO EXPECTATION, AS IT WOULD NOT ALLOW BLOOD TO BE SUCKED OUT OF THE AORTA DURING VENTING. THE DEVICE WAS REPLACED, BUT HAD THE SAME RESULTS. A THIRD VALVE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ALLEGATION IS AGAINST TWO VRV VALVES, BOTH FROM THE SAME LOT NUMBER AND BOTH USED FOR THE SAME CASE. THE THIRD VALVE WORKED CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859853 ↗
• MalfunctionSep 12, 2023Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A MEDTRONIC OVERPRESSURE RELIEF VALVE, IT WAS REPORTED THAT THE VALVE DID NOT PERF ORM TO EXPECTATION, AS IT WOULD NOT ALLOW BLOOD TO BE SUCKED OUT OF THE AORTA DURING VENTING. THE DEVICE WAS REPLACED, BUT HAD THE SAME RESULTS. A THIRD VALVE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728459 ↗

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