N/A (REF H12LP)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885825014261), received between May 12, 2025 and May 12, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryMay 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HASSAN H12LP BROKE INTO PIECES DURING SURGERY. AS REPORTED, THE PIECES WERE NOT RETRIEVED. AN X-RAY WAS NOT USED TO LOCATE THE PIECES AND A LARGER INCISION WAS NOT MADE TO RETRIEVE THE PIECES. THE SURGERY WAS DELAYED AS THE TEAM HAD TO REPLACE THE ITEM AND INFLATE THE ABDOMINAL CAVITY AGAIN. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22006567 ↗