NA BB8W76R12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000339340), received between Jul 12, 2023 and Jul 12, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 12, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED A LEAK IN THE PVC COIL CARDIOPLEGIA SYSTEM WHEN PRIMING. THE CUSTOMER OPENED A COMPLETELY NEW CUSTOM PACK TO GET A NEW PVC COIL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304231 ↗

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.