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AESCULAP BH443RRecalls & reported problems

Aesculap AG · ROCHESTER-PEAN Hemostatic Forceps, curved, 6 1/4", (160 mm), blunt, non-sterile, reusable · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653026562), received between Mar 31, 2021 and Mar 31, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. Jan 31, 2025Open, Classified

    The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

    Z-1309-2025 · Root cause: Use error · FDA record ↗

Most reported problems

Device problems

  • Break2

Patient problems

  • Insufficient Information2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 31, 2021Break; Break

    THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4) ((B)(4)).

    Patient problems: Insufficient Information

    MAUDE report 11595017 ↗
  • InjuryMar 31, 2021Break; Break

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH BH443R - ROCHESTER-PEAN FORCEPS CVD 160MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE INSTRUMENT BROKE DURING SURGERY. IT WAS REPORTED THAT THE ROCHESTER-PEAN FORCEPS CVD 160MM (PEAN CLAMP) BROKE DURING A CHOLECYSTECTOMY ON (B)(6) 2021. AN X-RAY WAS REQUIRED TO ENSURE THAT THE DEVICE FRAGMENT WAS SUCCESSFULLY REMOVED FROM THE SURGICAL FIELD. IT IS NOT KNOWN AT THIS TIME THE METHOD (OR TOOL) THAT WAS USED TO REMOVE THE FRAGMENT. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 11594941 ↗

Other HEMOSTAT devices

All HEMOSTAT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.