Affinity NT™ 95217Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000232122), received between Mar 8, 2022 and Jul 27, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionJul 27, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AFFINITY NT OXYGENATOR, IT WAS REPORTED THE DURING PREPARATION OF THE EXTRACORPOREAL CIRCULATION FOR NEW CASES THE CUSTOMER DETECTED A LEAK AT THE OXYGENATOR'S TEMPERATURE SENSOR. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING OR OTHER DEVICES WITHIN THE SAME PACKAGING AS THE OXYGENATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114690 ↗
• MalfunctionMay 16, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AFFINITY NT OXYGENATOR AND CARDIOTOMY VENOUS RESERVOIR, THE CUSTOMER REPORTED THAT THE SAMPLING PORT OF THE DEVICE WAS BROKEN. THE CUSTOMER STATED THAT THE PORT WAS PARTIALLY BROKEN. THE DEVICE WAS REPLACED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECTS OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION STATING THAT THE DEVICE WAS USED 7 DAYS FROM PRODUCT RECEIPT AND THE STORAGE ROOM TEMPERATURE WAS 20~25 °C AND THE HUMIDITY WAS 20~30%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407538 ↗
• MalfunctionMar 8, 2022Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS AFFINITY NT CARDIOTOMY VENOUS RESERVOIR (CVR), THE CUSTOMER NOTICED THAT THE BLOOD COMING INTO THE CARDIOTOMY SECTION AT THE REAR OF THE CVR SEEMED TO NOT BE COMING THROUGH THE SCREEN FILTER AS IT NORMALLY DOES. THE CUSTOMER SAID THAT THEIR HEPARIN DOSAGE WAS NORMAL AND THE ACTS WERE GREATER THAN 480 SECONDS THROUGHOUT THE CARDIOPULMONARY BYPASS PROCEDURE. USE OF THE CVR WAS CONTINUED AND THERE WAS NO PATIENT IMPACT AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693572 ↗