NA 560A (UDI 00613994776631)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994776631), received between Jun 7, 2023 and Nov 18, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionNov 18, 2025Smoking; Smoking

  IT WAS REPORTED THAT AT AN UNSPECIFIED TIME, THIS EXTERNAL DRIVE MOTOR PRODUCED SPARKS FROM THE MOTOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580428 ↗
• MalfunctionSep 18, 2023Contamination; Pumping Problem; Contamination; Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE EXTERNAL DRIVE MOTOR INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT DID NOT SPIN, AND A BLACK RING APPEARED ON THE MAGNETIC CIRCUIT CONNECTOR. USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764157 ↗
• MalfunctionJun 7, 2023Mechanical Problem; Noise, Audible; Mechanical Problem; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS EXTERNAL DRIVE MOTOR INSTRUMENT THE MOTOR WAS NOT CREATING THE PROPER FLOW AND THAT THE MOTOR WAS NOISY. INSTRUMENT WAS REPLACED WITH A BACKUP AND THERE WAS NO ADVERSE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 05 MAY 2021 STATING THAT THE HAND CRANK WAS NEVER USED DURING THIS CASE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CUSTOMER HAS DECLINED SERVICE AT THIS TIME. IF THE INSTRUMENT IS RETURNED FOR SERVICE IN THE FUTURE THE CASE WILL BE RE-OPENED AND REASSESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078985 ↗