AESCULAP BH135RRecalls & reported problems
Aesculap AG · KELLY Hemostatic Forceps, curved, 5 1/2", (140 mm), delicate, 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653025756), received between Mar 18, 2025 and Mar 18, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
Reports received per month
Recalls naming this device
- 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
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A HEMOSTAT VIA INFORMATION RECEIVED FROM MEDSUN (B)(4). ACCORDING TO THE COMPLAINT DESCRIPTION, DURING THE CREATION OF A LEFT BRACHIAL ARTERY TO LEFT AXILLARY VEIN ARTERIOVENOUS GRAFT PERFORMED IN (B)(6) 2025, THE TIP OF THE CRILE HEMOSTATIC FORCEPS BROKE WHILE THE SURGICAL TECHNICIAN WAS UNCLAMPING OFF THE SURGICAL SITE. AN X-RAY WAS PERFORMED AND THE RESULTS CONFIRMED THAT THERE WERE NO FRAGMENTS IN SITU. THE ADVERSE EVENT IS FILED UNDER AESCULAP REFERENCE NO. (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21634893 ↗
Other HEMOSTAT devices
- Centurion 66695Centurion Medical Products Corporation · HEMOSTAT2 recalls0 reports
- AESCULAP BH145RAesculap AG · HEMOSTAT1 recall5 reports
- AESCULAP BH443RAesculap AG · HEMOSTAT1 recall2 reports
- AESCULAP BH211RAesculap AG · HEMOSTAT1 recall0 reports
- AESCULAP MD469Aesculap, Inc. · HEMOSTAT1 recall0 reports
- AESCULAP BH155RAesculap AG · HEMOSTAT1 recall0 reports
- AESCULAP BH131RAesculap AG · HEMOSTAT1 recall0 reports
- AESCULAP BH154RAesculap AG · HEMOSTAT1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.