NA TL7Q72R6Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000247829), received between Jun 24, 2019 and Jun 24, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Obstruction of Flow” (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. How this data works · Data updated Oct 13, 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.

• InjuryJun 24, 2019Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK IT WAS NOTED THAT THERE WAS LOWER THAN EXPECTED VENOUS DRAINAGE UPON INITIATION OF BYPASS. THE SURGEON OPTED TO PUT AN ADDITIONAL 24 FR VENOUS CANNULA INTO THE SVC AND ATTACH IT TO A SEPARATE 3/8¿ VENOUS LINE WHICH THE PERFUSIONIST CONNECTED TO THE CARDIOTOMY VENOUS RESERVOIR PORT FOR DRAINAGE. THE SURGEON ALSO PLACED AN LV VENT INTO THE HEART TO DECOMPRESS THE VENTRICLE. THOSE TWO INTERVENTIONS IMPROVED THE VENOUS RETURN INTO THE BYPASS CIRCUIT TO ALLOW FOR THE TEAM TO COMPLETE THE PROCEDURE. AT THE END OF THE CASE WHEN THE PERFUSIONIST FILLED THE VENOUS LINE WITH CLEAR CRYSTALLOID SOLUTION TO ALLOW HIM TO PROCESS THE BLOOD IN THE LINE AND RETURN IT TO THE PATIENT HE NOTED THAT A PERFUSION ADAPTER WAS ACTUALLY INSIDE THE 1/2¿ VENOUS LINE TUBING NEAR THE VENOUS LINE PORT ON THE CARDIOTOMY VENOUS RESERVOIR. IT IS UNKNOWN IF THERE WERE ANY ADVERSE PATIENT EFFECTS. THE CUSTOMER HAS STATED THIS EVENT WAS DUE TO AN ERROR THAT HAPPENED ON THEIR END. THE CUSTOMER STATED THAT THE ADAPTER WAS LIKELY LODGED INSIDE A LARGER CONNECTOR INSIDE THE ACCESSORY POUCH OF SMALL ITEMS. WHEN THE CUSTOMER ATTACHED THE LARGER CONNECTOR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8726306 ↗

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.