Stealth® Clamps A3214Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915112769), received between May 22, 2025 and Sep 23, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873542 ↗
• 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 24APR2026: 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 27APR2026 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 28APR2026: THEY ARE BENT OR DON'T WORK. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 29APR2026: 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 6MAY2026: 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 S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211029 ↗
• 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 24APR2026: 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 27APR2026 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 28APR2026: THEY ARE BENT OR DON'T WORK. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 29APR2026: 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 6MAY2026: 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 S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211028 ↗
• 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 28APR26: THEY ARE BENT OR DON'T WORK. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 29APR26: 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 6MAY26: 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 STA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211027 ↗
• MalfunctionMay 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  TYPE OF PROCEDURE: AORTIC CLAMPING. EVENT DESCRIPTION: CLAMP SCISSORS AT THE JAW DURING AORTIC CLAMPING. VESSEL IS CLOSED OFF SUCCESSFULLY. SCISSORING CAUSES TRAUMA TO THE CLAMPED VESSEL ACCORDING TO THE SURGEON AND IS NOT DESIRABLE. PATIENT STATUS: PATIENT IS OK. INTERVENTION: UNKNOWN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071606 ↗