NA TL3A08R49Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000280208), received between Jun 16, 2023 and Jun 21, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT A CONNECTOR WITH LUER LEAKED THROUGHOUT THE CASE. THE CUSTOM TUBING PACK SPECIFICATIONS SHOW THAT THIS CONNECTOR SHOULD BE SOLVENT BONDED AND THE CUSTOMER WAS SKEPTICAL THAT IT WAS, BECAUSE IT WAS LEAKING AND AFTER ONE OF THE CASES THAT HAD A LEAK THE PERFUSIONIST WAS ABLE TO "PUSH THE TUBING FURTHER ONTO CONNECTOR". THIS CONNECTOR IS ON LINE 7 OF THE CUSTOM TUBING PACK SPECIFICATIONS. THE CUSTOM PACK WAS USED FOR THE ENTIRETY OF THE CASE. APPROXIMATELY 50 CC OF BLOOD WAS LOST DUE TO THE LEAK. NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169805 ↗
• MalfunctionJun 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT A CONNECTOR WITH LUER LEAKED THROUGHOUT THE CASE. THE CUSTOM TUBING PACK SPECIFICATIONS SHOW THAT THIS CONNECTOR SHOULD BE SOLVENT BONDED AND THE CUSTOMER WAS SKEPTICAL THAT IT WAS, BECAUSE IT WAS LEAKING AND AFTER ONE OF THE CASES THAT HAD A LEAK THE PERFUSIONIST WAS ABLE TO "PUSH THE TUBING FURTHER ONTO CONNECTOR". THIS CONNECTOR IS ON LINE 7 OF THE CUSTOM TUBING PACK SPECIFICATIONS. THE CUSTOM PACK WAS USED FOR THE ENTIRETY OF THE CASE. APPROXIMATELY 50 CC OF BLOOD WAS LOST DUE TO THE LEAK. NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169767 ↗
• MalfunctionJun 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT A CONNECTOR WITH LUER LEAKED THROUGHOUT THE CASE. THE CUSTOM TUBING PACK SPECIFICATIONS SHOW THAT THIS CONNECTOR SHOULD BE SOLVENT BONDED AND THE CUSTOMER WAS SKEPTICAL THAT IT WAS, BECAUSE IT WAS LEAKING AND AFTER ONE OF THE CASES THAT HAD A LEAK THE PERFUSIONIST WAS ABLE TO "PUSH THE TUBING FURTHER ONTO CONNECTOR". THIS CONNECTOR IS ON LINE 7 OF THE CUSTOM TUBING PACK SPECIFICATIONS. THE CUSTOM PACK WAS USED FOR THE ENTIRETY OF THE CASE. APPROXIMATELY 50 CC OF BLOOD WAS LOST DUE TO THE LEAK. NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169740 ↗
• MalfunctionJun 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT A CONNECTOR WITH LUER LEAKED THROUGHOUT THE CASE. THE CUSTOM TUBING PACK SPECIFICATION SHOW THAT THIS CONNECTOR SHOULD BE SOLVENT BONDED AND THE CUSTOMER WAS SKEPTICAL THAT IT WAS, BECAUSE IT WAS LEAKING AND AFTER ONE OF THE CASES THAT HAD A LEAK THE PERFUSIONIST WAS ABLE TO "PUSH THE TUBING FURTHER ONTO CONNECTOR". THIS CONNECTOR IS ON LINE 7 OF THE CUSTOM TUBING PACK SPECIFICATION. THE CUSTOM PACK WAS USED FOR THE ENTIRETY OF THE CASE. APPROXIMATELY 50 CC OF BLOOD WAS LOST DUE TO THE LEAK. NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142442 ↗

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.