ATRAUMATARecalls & reported problems across all models
Aesculap AG · 39 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one ATRAUMATA model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 3
We found 39 models of ATRAUMATA by Aesculap AG in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Sep 18, 2020 and May 11, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).
3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
ATRAUMATA recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 31, 2025Open, Classified
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Z-1311-2025 · Root cause: Use error · names 13 of these models · Recall details · FDA record ↗
- Jan 31, 2025Open, Classified
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Z-1310-2025 · Root cause: Use error · names 20 of these models · Recall details · FDA record ↗
- Jan 31, 2025Open, Classified
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Z-1308-2025 · Root cause: Use error · names 4 of these models · Recall details · FDA record ↗
Most reported ATRAUMATA problems
Device problems
- Human-Device Interface Problem1
- Mechanical Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
ATRAUMATA models
39 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ATRAUMATA BJ550RCLAMP, UTERINE1 recall0 reports
- ATRAUMATA BJ551RCLAMP, UTERINE1 recall0 reports
- ATRAUMATA BJ552RCLAMP, UTERINE1 recall0 reports
- ATRAUMATA BJ553RCLAMP, UTERINE1 recall0 reports
- ATRAUMATA FB440RFORCEPS1 recall0 reports
- ATRAUMATA FB441RFORCEPS1 recall0 reports
- ATRAUMATA FB442RFORCEPS1 recall0 reports
- ATRAUMATA FB443RFORCEPS1 recall0 reports
- ATRAUMATA FB446RFORCEPS1 recall0 reports
- ATRAUMATA FB447RFORCEPS1 recall0 reports
- ATRAUMATA FB448RFORCEPS1 recall0 reports
- ATRAUMATA FB458RCLAMP1 recall0 reports
- ATRAUMATA FB459RCLAMP1 recall0 reports
- ATRAUMATA FB461RCLAMP1 recall0 reports
- ATRAUMATA FB462RCLAMP1 recall0 reports
- ATRAUMATA FB469RCLAMP1 recall0 reports
- ATRAUMATA FB483RFORCEPS1 recall0 reports
- ATRAUMATA FB486RFORCEPS1 recall0 reports
- ATRAUMATA FB487RFORCEPS1 recall0 reports
- ATRAUMATA FB496RFORCEPS1 recall0 reports
- ATRAUMATA FB498RFORCEPS1 recall0 reports
- ATRAUMATA FB499RFORCEPS1 recall0 reports
- ATRAUMATA FB526RFORCEPS1 recall0 reports
- ATRAUMATA FB527RFORCEPS1 recall0 reports
- ATRAUMATA FB533RFORCEPS1 recall0 reports
- ATRAUMATA FB534RFORCEPS1 recall0 reports
- ATRAUMATA FB563RFORCEPS1 recall0 reports
- ATRAUMATA FB567RCLAMP1 recall0 reports
- ATRAUMATA FB568RCLAMP1 recall0 reports
- ATRAUMATA FB569RCLAMP1 recall0 reports
- ATRAUMATA FB570RFORCEPS1 recall0 reports
- ATRAUMATA FB729RCLAMP1 recall0 reports
- ATRAUMATA FB730RCLAMP1 recall0 reports
- ATRAUMATA FB736RCLAMP1 recall0 reports
- ATRAUMATA FB737RCLAMP1 recall0 reports
- ATRAUMATA FB738RCLAMP1 recall0 reports
- ATRAUMATA FB741RFORCEPS1 recall0 reports
- ATRAUMATA FB411RFORCEPS1 report
- ATRAUMATA FB495RCLAMP1 report
Recent ATRAUMATA adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2023Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FB411R - DE'BAKEY ATR.FCPS 1.5MM STR150MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE DEVICE ONCE TORE TISSUE DURING A HERNIA PROCEDURE. IT WAS NOTED THAT THE "TEETH" DID NOT APPROXIMATE CORRECTLY. A TEMPORARY IMPAIRMENT OCCURRED; THERE WAS NO FURTHER PATIENT HARM NOR SURGICAL DELAY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16913152 ↗InjurySep 18, 2020Mechanical Problem; Mechanical Problem
ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00444 (400482527 - FB495R - QUANTITY: 3).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 10554714 ↗
Other Aesculap AG products
All Aesculap AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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