Stealth® Clamps A3216Recalls & reported problems
Applied Medical Resources Corporation · Vascular Clamp, Reusable · Class 2
Data updated Oct 13, 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 00607915113254), received between May 18, 2026 and May 18, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Open or Close” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Open or Close1
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.
MalfunctionMay 18, 2026Difficult to Open or Close
PROCEDURE PERFORMED: NA. EVENT DESCRIPTION: PCF INFORMATION: THESE ARE MAD VASCULAR CLAMPS. PLEASE REPLACE 3 UNITS OF CLAMP REFERENCE A3214 AND 3 UNITS OF CLAMP REFERENCE A3216. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON (B)(6) 2026: I DIDN'T UNDERSTAND THE PROBLEM EITHER. ACTUALLY, THERE ARE ONLY TWO DEFECTIVE UNITS (1 REF 3214 AND 1 REF 3216). THEY WANT MORE UNITS TO HAVE MORE AVAILABLE IN THE OPERATING ROOM. INFORMATION RECEIVED ON (B)(6) 2026 VIA EMAIL BY CUSTOMER: TWO A3214 CLAMPS WERE JUST BROUGHT BACK TO ME TODAY. SO NOW I HAVE 3 A3214S AND 1 A3216 THAT AREN'T WORKING. THAT EXPLAINS WHY WE ASKED YOU FOR THREE. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON (B)(6) 2026: THEY ARE BENT OR DON'T WORK. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON (B)(6) 2026: THE PROBLEM IS THAT THE CLAMPS DO NOT OPEN AND CLOSE EASILY, THE CLOSING CLANS ARE NO LONGER OPPOSITE EACH OTHER. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON (B)(6) 2026: THE JAWS HAVE DIFFICULTY CLOSING COMPLETELY TO LOCK THE CLIP ONTO THE VESSEL. DIFFICULTY TO OPEN THE DEVICE AFTER ATTACHING THE CLIP ON THE VESSEL. INTERVENTION: NA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25211023 ↗
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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.
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