Performer™ RR5100052Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994160638), received between May 24, 2022 and May 19, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K052555); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2023Pumping Problem; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS PERFORMER INSTRUMENT IT WAS NOTED THAT THE SUCKER PUMP WAS NOT STARTING WHEN THE START BUTTON WAS PRESSED. THE CUSTOMER STATED THAT THE PUMP DID START AFTER A FEW ATTEMPTS. USE OF THE INSTRUMENT WAS CONTINUEDWITH NO RESULTING ADVERSE PATIENT EFFECT. THE HAND CRANK WAS NOT USED TO MAINTAIN FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16960365 ↗
• MalfunctionNov 23, 2022Device Alarm System; Power Problem; Device Alarm System; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PERFORMER INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT SHUT OFF ON IT'S OWN. IT WAS ALSO REPORTED THAT THERE WAS A BAD CONNECTION TO THE POWER ENTRY AND ON REBOOT AN ERROR WAS DISPLAYED. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THIS INSTRUMENT WILL BE TAKEN OUT OF SERVICE. THE CUSTOMER HAS CHOSEN NOT TO HAVE THIS UNIT REPAIRED. THE BACK-UP WILL BE PUT IN IT¿S PLACE. ERROR CODE "A41 A041: BCL COMMUNICATION ISSUE" DISPLAYED. IT IS UNKNOWN IF A HANDCRANK WAS USED TO MAINTAIN FLOW WHEN THE INSTRUMENT CHANGE OUT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15850614 ↗
• MalfunctionMay 24, 2022Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PERFORMER INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT SHOWED A LOW BATTERY A LARM. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488159 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052555. One submission often covers many models, so check the product and lot details in each record.

• Z-1090-2007 · Jun 4, 2007 · Terminated
  Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary