NA HY7F85R16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000287719), received between Dec 15, 2021 and Dec 15, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionDec 15, 2021Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS CUSTOM PACK, THE CUSTOMER REPORTED THAT AFTER THE PROCEDURE WAS COMPLETED THEY WERE REMOVING THE PUMP HEADER TUBING AND NOTICED THAT A CRACK WAS IN THE TUBING. THE PERFUSIONIST DISCOVERED THE CRACK AT THE END OF THE CASE WHEN FLUSHING CLEAR SOLUTION THRU THE TUBING. THE TUBING WAS IN POSITIVE PRESSURE SINCE IT WAS LOCATED IN THE ROLLER HEAD OF THE HEART LUNG MACHINE. NO FLUID HAD LEAKED DURING OR AFTER THE PROCEDURE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010279 ↗
• MalfunctionDec 15, 2021Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS CUSTOM PACK, THE CUSTOMER REPORTED THAT AFTER THE PROCEDURE WAS COMPLETED THEY WERE REMOVING THE PUMP HEADER TUBING AND NOTICED THAT A CRACK WAS IN THE TUBING. THE PERFUSIONIST DISCOVERED THE CRACK AT THE END OF THE CASE WHEN FLUSHING CLEAR SOLUTION THRU THE TUBING. THE TUBING WAS IN POSITIVE PRESSURE SINCE IT WAS LOCATED IN THE ROLLER HEAD OF THE HEART LUNG MACHINE. NO FLUID HAD LEAKED DURING OR AFTER THE PROCEDURE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010239 ↗

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.