Affinity Fusion™ RCL841Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20643169178025), received between Jan 21, 2026 and Jan 29, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (5 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE RECIRCULATION LINES FOR THE FUSION OXYGENATORS AND CARDIOTOMY VENOUS RESERVOIRS, THE CUSTOMER REPORTED THAT THE STERILE PACKAGING WAS NOT CLOSED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209545 ↗
• MalfunctionJan 29, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE RECIRCULATION LINES FOR THE FUSION OXYGENATORS AND CARDIOTOMY VENOUS RESERVOIRS, THE CUSTOMER REPORTED THAT THE STERILE PACKAGING WAS NOT CLOSED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209519 ↗
• MalfunctionJan 29, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE RECIRCULATION LINES FOR THE FUSION OXYGENATORS AND CARDIOTOMY VENOUS RESERVOIRS, THE CUSTOMER REPORTED THAT THE STERILE PACKAGING WAS NOT CLOSED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209463 ↗
• MalfunctionJan 29, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE RECIRCULATION LINES FOR THE FUSION OXYGENATORS AND CARDIOTOMY VENOUS RESERVOIRS, THE CUSTOMER REPORTED THAT THE STERILE PACKAGING WAS NOT CLOSED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209406 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE RECIRCULATION LINES FOR THE FUSION OXYGENATORS AND CARDIOTOMY VENOUS RESERVOIRS, THE CUSTOMER REPORTED THAT THE STERILE PACKAGING WAS NOT CLOSED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130494 ↗