NA HY6C54R20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000251581), received between Jun 15, 2023 and Jun 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Decoupling” (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 15, 2023Decoupling; Obstruction of Flow; Decoupling; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THE CUSTOM PACK CONE DECOUPLED DURING AN ECMO CASE. THE CONE WAS CHANGED OUT SUCCESSFULLY AND FLOW WAS RE-ESTABLISHED. THERE WERE NO ADVERSE PATIENT EFFECTS. ADDITIONAL INFORMATION: THE CPS WAS IN USE FOR 65 HOURS BEFORE THE CONE DECOUPLED. THE RPMS WERE 3300.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135157 ↗

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.