CHALLENGER TI PL522RRecalls & reported problems
Aesculap AG · CHALLENGER TI Clip Applier (Shaft Only), multi-fire, (310 mm), diam. 5 mm, to be used with: PL510R, PL572T · 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 04038653208463), received between Jul 8, 2021 and Jul 8, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Ejection” (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
- Unintended Ejection1
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.
MalfunctionJul 8, 2021Unintended Ejection; Unintended Ejection
INVOLVED COMPONENTS: PL510R - HANDLE F/PL506R & PL508R - LOT UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12134821 ↗
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- Endo Clip III 176630BCovidien LP · Applier, surgical, clip312 reports
- LIGACLIP MCM20Ethicon Endo-Surgery, LLC · Applier, surgical, clip308 reports
- LIGACLIP MCM30Ethicon Endo-Surgery, LLC · Applier, surgical, clip1 death236 reports
- WECK IPN915189Teleflex Incorporated · Applier, surgical, clip221 reports
- LIGACLIP MSM20Ethicon Endo-Surgery, LLC · Applier, surgical, clip152 reports
- LIGACLIP LX107Ethicon Endo-Surgery, LLC · Applier, surgical, clip105 reports
- WECK IPN028280Teleflex Incorporated · Applier, surgical, clip93 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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