NA 02.226.318Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982059147), received between Sep 7, 2018 and Sep 7, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

1 other recall cover devices cleared under the same FDA submission (K012945, K021556, K161616); 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 18, 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.

• MalfunctionSep 7, 2018Device-Device Incompatibility; Device-Device Incompatibility

  FURTHER IT WAS REPORTED THAT THERE WAS NO DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7856691 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012945, K021556, K161616. One submission often covers many models, so check the product and lot details in each record.

• Z-0890-2013 · Feb 12, 2013 · Terminated
  Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antiprur