NA ATLS21Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169108356), received between Jan 21, 2026 and Jan 21, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AUTOLOG ONE SOURCE PACK, THE DEVICE HAD A DEFECT. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PACKAGING SEAL WAS OBSERVED TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133307 ↗