Intersept® Custom Tubing Pack 9156R2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00673978558455), 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).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• 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 ↗