AESCULAP PL548SRecalls & reported problems
Aesculap AG · ATR.VASCULAR CLIP 25MM CVD.3.43N ARTERI. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963094089), received between Mar 18, 2021 and Mar 18, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Jam” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Mechanical Jam1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED TO AESCULAP (B)(4) THAT A ATR.VASCULAR CLIP 25MM CVD.3.43N ARTERI. (PART # PL548S) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE PATIENT SUDDENLY DROPPED OUT WHILE GRASPING THE BLOOD VESSEL WITH THE DEVICE. DUE TO THE OCCURRENCE OF THIS EVENT, THE PATIENT WAS TRANSFERRED TO OPEN SURGERY. THERE WAS NO INFECTION AND NO HEALTH HAZARD TO PATIENT REPORTED. NO INFORMATION WAS PROVIDED AS TO A SPECIFIC DEVICE MALFUNCTION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: Insufficient Information
MAUDE report 11518654 ↗
Other CLAMP, VASCULAR devices
- Heartstring III System 3.8MM HSK-3038Maquet Cardiovascular LLC · Clamp, Vascular1 recall4 deaths809 reports
- Heartstring III System 4.3MM HSK-3043Maquet Cardiovascular LLC · Clamp, Vascular1 recall265 reports
- TR BAND TRB24-REGTerumo Medical Corporation · CLAMP, VASCULAR284 reports
- TR BAND TRB24-REGTerumo Medical Corporation · CLAMP, VASCULAR256 reports
- HeartString III Proximal Seal HS-3045Maquet Cardiovascular LLC · Clamp, Vascular1 recall187 reports
- TR BAND TRB29-LRGTerumo Medical Corporation · CLAMP, VASCULAR67 reports
- TR BAND TRB29-LRGTerumo Medical Corporation · CLAMP, VASCULAR65 reports
- Flo-Thru Intraluminal Shunt® FT-12225Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page