NA HY9Q42R8Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000175696), received between Jun 16, 2023 and Jun 16, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

1 other recall cover devices cleared under the same FDA submission (K171308); 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED A CARDIOPLEGIA PIECE SHEARED OFF. THE CUSTOMER HAD A 3/16 CONNECTOR AND TABLE LINE, THEY WENT UP TO THE PUMP AND WERE ABOUT TO PRIME, WITH NO EXTREME PRESSURE, IT BROKEOFF. THE CUSTOM TUBING PACK WAS REPLACED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP: HAPPENED JUST AFTER GOING ON BYPASS, HEART STILL BEATING, PATIENT WAS WARM. IT BROKE WHILE HE WAS BRINGING BLOOD UP TO THE TABLE AS THEY WERE FLUSHING THE PLEGE OCTOPUS. PATIENT UNAFFECTED. CONNECTOR CUT OUT AND 3/16 3/16 CONNECTOR SPLICED IN. LINE WAS RE-PRIMED AND DE-AIRED. CROSS CLAMP WAS THEN PUT ON AND PROCEDURE MOVED ON AS NORMAL. MINIMAL BLOOD LOSS. LESS THAN 20CC. NO PRODUCTS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142345 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171308. One submission often covers many models, so check the product and lot details in each record.

• Z-0535-2018 · Jan 3, 2018 · Terminated
  Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.