AESCULAP PL520RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963313173), received between Jan 26, 2021 and Sep 8, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UPDATE: AFTER INVESTIGATION RESULTS WERE REVIEWED, THE PRODUCTS WERE CONFIRMED. INVOLVED COMPONENTS: PL520R - CHALLENGER TI-P HANDLE (9610612-2021-00613) (B)(4). ASSOCIATED MEDWATCH REPORTS: PL536R - SHAFT COMPL.D:10MM L:370MM (9610612-2022-00307) (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439505 ↗
• InjurySep 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UPDATE: AFTER INVESTIGATION RESULTS WERE REVIEWED, THE PRODUCTS WERE CONFIRMED. INVOLVED COMPONENTS PL520R - CHALLENGER TI-P HANDLE (9610612-2021-00613) (B)(4). ASSOCIATED MEDWATCH REPORTS: PL536R - SHAFT COMPL.D:10MM L:370MM (9610612-2022-00307) (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12424145 ↗
• MalfunctionJan 26, 2021Break; Break

  IT WAS REPORTED TO AESCULAP AG THAT A CHALLENGER TI-P HANDLE (PART # PL520R) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PNEUMATIC APPLIER WAS OBSERVED TO BE BROKEN AT THE OPENING. REPORTEDLY, THE CLIP WAS DEFLECTED AND FAILED TO CLIP AT THE DESIRED LOCATION WHILE THE PATIENT HAD ARTERIAL BLEEDING. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ALTHOUGH REQUESTED, ADDITIONAL CASE AND PATIENT INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). CONCOMMITANT DEVICES: PL536R-UNKNOWN, PL520R-62407650.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11230872 ↗