Affinity NT™ 95215Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000232085), received between Jul 25, 2022 and Jul 13, 2023 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathJul 13, 2023Increase in Pressure; Increase in Pressure

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE USE OF AN AFFINITY NT OXYGENATOR, THE CUSTOMER REPORTED THAT THEY HAD EXPERIENCED A H IGH-PRESSURE EXCURSION. THE CUSTOMER STATED THAT THE HIGH PRESSURE EXCURSION OCCURRED WITHIN THE FIRST 10 MINUTES OF INITIATION OF CARDIOPULMONARY BYPASS AND IT WAS A SLOW BUT STEADY INCREASE WITHIN MINUTES OF INITIATION. THE CUSTOMER STATED THAT THE HIGH PRESSURE EXCURSION IS OFTEN ASSOCIATED BUT NOT ALWAYS WITH TEMPERATURE COOLING OF THE PATIENT AND INITIAL DELIVERY OF COLD CARDIOPLEGIA TO THE MYOCARDIUM. THE CUSTOMER STATED THAT THE PRESSURE CONTINUALLY INCREASED OVER A 10 TO 20 MINUTE PERIOD AND HAD ACTION NOT BEEN TAKEN IT WOULD HAVE FURTHER CONTINUED TO INCREASE TO A DANGEROUS LEVEL IMPACTING BLOOD FLOW AND PROPER OXYGENATION OF THE BLOOD. THE CUSTOMER STATED THAT THE ISSUE WAS RESOLVED BY REWARMING THE PATIENT AND ADMINISTERING OF 100 TO 200 ML OF 25% ALBUMIN AND/OR 200 TO 400 UG DOSE OF NITROPRUSSIDE. THE OXYGENATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: THE CUSTOMER'S STANDARD PRIME SOLUTION CONTAINS 2L OF PLASMALYTE A, 25 GM OF MANNITOL AND (B)(4) UNITS OF H

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17314998 ↗
• MalfunctionJul 25, 2022Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE AFFINITY NT CARDIOTOMY VENOUS RESERVOIRS (CVRS) AND OXYGENATORS, IT WAS REPORTED THAT CRACKS WERE SEEN IN THE CVRS AND OXYGENATORS. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THAT THEY DID NOT HAVE ANY PROBLEM IN THE WAY OF STORAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094043 ↗
• MalfunctionJul 25, 2022Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE AFFINITY NT CARDIOTOMY VENOUS RESERVOIRS (CVRS) AND OXYGENATORS, IT WAS REPORTED THAT CRACKS WERE SEEN IN THE CVRS AND OXYGENATORS. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THAT THEY DID NOT HAVE ANY PROBLEM IN THE WAY OF STORAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094004 ↗
• MalfunctionJul 25, 2022Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE AFFINITY NT CARDIOTOMY VENOUS RESERVOIRS (CVRS) AND OXYGENATORS, IT WAS REPORTED THAT CRACKS WERE SEEN IN THE CVRS AND OXYGENATORS. SEE THE ATTACHED PHOTOS. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THAT THEY DID NOT HAVE ANY PROBLEM IN THE WAY OF STORAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093880 ↗