NA 8H23R12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000219659), received between Aug 13, 2025 and Aug 13, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Contamination; Material Puncture/Hole; Contamination; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE DEVICE HAD A FOREIGN MATERIAL IN THE 3/8 CONNECTOR IN THE ARTERIAL LINE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THIS ISSUE APPEARS TO BE EXCESS BONDING MATERIAL, NOT A CRACKED CONNECTOR. THIS DID NOT OCCUR IN MULTIPLE PACKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791655 ↗
• MalfunctionAug 13, 2025Contamination; Material Puncture/Hole; Contamination; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS A FOREIGN MATERIAL IN THE AV LOOP. THE DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT HAIR-LIKE MATERIAL WAS SEEN ON THE DEVICE. IT WAS CONFIRMED THAT THE CONNECTOR WAS NOT CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791652 ↗

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.