AESCULAP BH145RRecalls & reported problems
Aesculap AG · CRILE Hemostatic Forceps, curved, 5 1/2", (140 mm), delicate, blunt, non-sterile, reusable · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04038653025800), received between Nov 3, 2021 and Dec 8, 2023 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Integrity Problem4
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 2023Fracture; Fracture
IT WAS REPORTED TO AESCULAP INC. THAT A CRILE FORCEPS CVD 140MM (PART# BH145R) WAS USED DURING A CESAREAN PROCEDURE ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT THE DEVICE HAD BROKE DURING THE PROCEDURE. THE FRAGMENT WAS ABLE TO BE RETREIVED AND AN X-RAY WAS PERFORMED ON THE PATIENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18291816 ↗MalfunctionNov 3, 2021Material Integrity Problem; Material Integrity Problem
THIS CASE (B)(4) IS A DOUBLETTE OF (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12747466 ↗MalfunctionNov 3, 2021Material Integrity Problem; Material Integrity Problem
THIS CASE (B)(4) IS A DOUBLETTE OF (B)(4) AND WILL BE CLOSED AS A DOUBLETTE. THEREFORE IT IS NO REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12747465 ↗MalfunctionNov 3, 2021Material Integrity Problem; Material Integrity Problem
THIS CASE (B)(4) WILL BE CLOSED AS A DOUBLETTE OF (B)(4). THEREFORE IT IS NO LONGER REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12747460 ↗MalfunctionNov 3, 2021Material Integrity Problem; Material Integrity Problem
THIS CASE IS NOT ASSOCIATED WITH THE LISTED MEDWATCH REPORTS BELOW. ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00726 (400533509 BH145R) 9610612-2021-00727 (400533511 BH145R) 9610612-2021-00728 (400533513 BH145R) 9610612-2021-00687 (400530950 BH145R) IT IS POSSIBLY ASSOCIATED WITH 400529799.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12747459 ↗
Other HEMOSTAT devices
- Centurion 66695Centurion Medical Products Corporation · HEMOSTAT2 recalls0 reports
- AESCULAP BH443RAesculap AG · HEMOSTAT1 recall2 reports
- AESCULAP BH135RAesculap AG · HEMOSTAT1 recall1 report
- AESCULAP BH176RAesculap AG · HEMOSTAT1 recall0 reports
- AESCULAP BH171RAesculap AG · HEMOSTAT1 recall0 reports
- AESCULAP BH445RAesculap AG · HEMOSTAT1 recall0 reports
- AESCULAP BH648RAesculap AG · HEMOSTAT1 recall0 reports
- AESCULAP BH178RAesculap AG · HEMOSTAT1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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