Custom Perfusion System BB0H30R23Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169356078), received between Jun 20, 2023 and Jul 5, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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.

• MalfunctionJul 5, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF TWO CUSTOM TUBING PACKS, THE 1/4 CP TUBING RUPTURED DURING THE CASE. BOTH CUSTOM PACKS WERE USED DURING THE SAME PROCEDURE ON THE SAME PATIENT. THE CARDIOPLEGIA WAS REPLACED TO COMPLETE THE CASE. THERE WAS 50 CC OF BLOOD LOSS AS A RESULT OF THE RUPTURE. NO BLOOD TRANSFUSION WAS REQUIRED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17254294 ↗
• MalfunctionJun 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS CUSTOM TUBING PACK THERE WAS A LEAK NOTED COMING FROM THE CARDIOPLEGIA LINE. APPROXIMATELY 5 CC OF BLOOD WAS LOST DUE TO THE LEAK. NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE LEAK. THE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162872 ↗
• MalfunctionJun 20, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK IT WAS NOTED THAT THERE WAS A SPLIT IN THE CARDIOPLEGIA TUBING. THE PACK WILL BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17161052 ↗