AESCULAP BV120RRecalls & reported problems
Aesculap, Inc. · HENLY Retractor (Self Retaining), (180 mm), non-sterile, reusable, Set · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963458645), received between Apr 20, 2021 and Apr 20, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Mechanical Problem1
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.
MalfunctionApr 20, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH BV120R - HENLY RETRACTOR SET COMPLETE 180MM. ACCORDING TO THE COMPLAINT DESCRIPTION, IT WAS REPORTED THAT THE HENLY RETRACTOR SET COMPLETE 180MM WAS RECEIVED AND WHEN INSPECTED IT WAS NOTED THAT THE DEVICE CAME WITH SOME TYPE OF DEFECT, REPORTEDLY, THE BV120R ONE OF THE SIDE BLADES WAS VERY DIFFICULT TO PUT ON. ALL OTHER PIECES SEEMED TO ASSEMBLE FINE BUT THIS ONE FELT LIKE IT WAS GETTING STUCK. THE DEVICE MALFUNCTION WAS NOTED ON (B)(6) 2021. THERE WAS NO PATIENT INVOLVEMENT AND THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DELAY IN A SURGERY. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11693727 ↗
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- Fathom MR2-102050Seaspine Orthopedics Corporation · RETRACTOR1 recall1 report
- Omni-Tract® 3104RIntegra Lifesciences Corporation · RETRACTOR1 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
- 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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