NA HY7W39R20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000211714), received between Jun 13, 2023 and Jun 13, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• MalfunctionJun 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, OF THE CUSTOM TUBING PACK THE CUSTOMER REPORTED THAT THE PRESSURE DOME WOULD NOT HOLD A SEAL AND MEASURE PRESSURE. THE CUSTOMER STATED THAT THE PRESSURE DOME SEEMED TO LEAK ON THE AIR SIDE (MANOMETER SIDE), NOT ON THE FLUID SIDE OF THE DOMES. IT IS SUSPECTED THAT AIR (NOT FLUID) WAS LEAKING FROM THE AIR SIDE OF THE PRESSURE DOME BECAUSE IT WOULDN'T HOLD A PRESSURE READING. THE PERFUSIONIST CHANGED THE PRESSURE DOME OUT FOR A NEW PRESSURE DOME. THERE WAS NO ADVERSE PATIENT EFFECT AS A RESULT OF THIS ISSUE. ADDITIONAL INFORMATION: THERE WAS NO AIR IN SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119373 ↗
• MalfunctionJun 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, OF THE CUSTOM TUBING PACK THE CUSTOMER REPORTED THAT PRESSURE DOME WOULD NOT HOLD A SEAL AND MEASURE PRESSURE. THE CUSTOMER STATED THAT THE PRESSURE DOME SEEMED TO LEAK ON THE AIR SIDE (MANOMETER SIDE), NOT ON THE FLUID SIDE OF THE DOMES. IT IS SUSPECTED THAT AIR (NOT FLUID) WAS LEAKING FROM THE AIR SIDE OF THE PRESSURE DOME BECAUSE IT WOULDN'T HOLD A PRESSURE READING. THE PERFUSIONIST WAS ABLE TO TIE BAND THE DOME AND THAT SEEMED TO IMPROVE THE LEAK. THIS PRESSURE DOME WAS USED FOR THE ENTIRE CASE. THERE WAS NO ADVERSE PATIENT EFFECT AS A RESULT OF THIS ISSUE. THERE WAS NO AIR IN SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119365 ↗

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.