NA HY8N48R13Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000200336), received between Jun 12, 2023 and Jun 12, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS CUSTOM TUBING PACK A LEAK WAS OBSERVED FROM THE TUBING AT THE CONNECTION. THE CUSTOMER STATED THAT THERE WAS A ZIP TIE BUT NO ADHESIVE AT THE SITE. THE CUSTOMER CONTINUED TO USE THE PACK AFTER OBSERVING THE LEAK. THEY CLAMPED TO CONTROL THE LEAK. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION: THE AMOUNT OF BLOOD LOST DUE TO THE LEAK WAS ASKED BUT IS UNKNOWN. NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE LEAK. THERE WAS NO DAMAGE TO THE TUBING OBSERVED, JUST BONDING DID NOT BOND AND THE ZIP TIE WAS LOOSE. THERE WAS NO VISIBLE AIR IN THE SYSTEM/TUBING. THE EXACT LOCATION OF THE LEAK IN THE CUSTOM TUBING PACK SPECIFICATION WAS LINE 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106397 ↗
• MalfunctionJun 12, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS CUSTOM TUBING PACK A LEAK WAS OBSERVED FROM THE TUBING AT THE CONNECTION. THE CUSTOMER STATED THAT THERE WAS A ZIP TIE BUT NO ADHESIVE AT THE SITE. THE CUSTOMER CONTINUED TO USE THE PACK AFTER OBSERVING THE LEAK. THEY CLAMPED TO CONTROL THE LEAK. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION: THE AMOUNT OF BLOOD LOST DUE TO THE LEAK WAS ASKED BUT IS UNKNOWN. NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE LEAK. THERE WAS NO DAMAGE TO THE TUBING OBSERVED, JUST BONDING DID NOT BOND AND THE ZIP TIE WAS LOOSE. THERE WAS NO VISIBLE AIR IN THE SYSTEM/TUBING. THE EXACT LOCATION OF THE LEAK IN THE CUSTOM TUBING PACK SPECIFICATION WAS LINE 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106388 ↗
• MalfunctionJun 12, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS CUSTOM TUBING PACK A LEAK WAS OBSERVED FROM THE TUBING AT THE CONNECTION. THE CUSTOMER STATED THAT THERE WAS A ZIP TIE BUT NO ADHESIVE AT THE SITE. THE CUSTOMER CONTINUED TO USE THE PACK AFTER OBSERVING THE LEAK. THEY CLAMPED TO CONTROL THE LEAK. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION: THE AMOUNT OF BLOOD LOST DUE TO THE LEAK WAS ASKED BUT IS UNKNOWN. NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE LEAK. THERE WAS NO DAMAGE TO THE TUBING OBSERVED, JUST BONDING DID NOT BOND AND THE ZIP TIE WAS LOOSE. THERE WAS NO VISIBLE AIR IN THE SYSTEM/TUBING. THE EXACT LOCATION OF THE LEAK IN THE CUSTOM TUBING PACK SPECIFICATION WAS LINE 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106378 ↗

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.