Stealth® Clamps A3203Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00607915112721), received between Mar 30, 2017 and Mar 2, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Patient Device Interaction Problem

  NAME OF PROCEDURE BEING PERFORMED: UROLOGIC PROCEDURE ON THE SPERMATIC CORD. EVENT DESCRIPTION: PARALLEL CLAMPING NO LONGER POSSIBLE DUE TO FREQUENT USE. IT'S A SERVICE REQUEST: ORIGINAL CONDITIONS PROBABLY NOT REPAIRABLE. PLEASE PROVIDE A FREE REPLACEMENT. PRODUCT IS ALREADY IN AME. OR NURSE SENDS THE A3203 CLAMP TO STERILIZATION. ROUTINE FUNCTIONALITY CHECK ACCORDING TO THEIR STANDARDS: STERILIZATION SENDS IT TO US WITH A SERVICE REQUEST. NO PATIENTS AFFECTED. INTERVENTION: THEY USE THEIR SECOND CLAMP. PATIENT STATUS: NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24488181 ↗
• MalfunctionAug 19, 2025Failure to Align; Patient Device Interaction Problem; Failure to Align; Patient Device Interaction Problem

  PROCEDURE PERFORMED: UROLOGICAL PROCEDURE ON THE SPERMATIC CORD. EVENT DESCRIPTION: THE STEALTH CLAMP WAS USED REGULARLY FOR A UROLOGICAL PROCEDURE ON THE SPERMATIC CORD. REASON: TEAR DUE TO FREQUENT USE. PARALLEL CLAMPING NO LONGER POSSIBLE DUE TO FREQUENT USE. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 11AUG25: THE SURGEON DESCRIBES IT COLLOQUIALLY AS LOOKING LIKE ¿FINGER CROSSING¿ OF THE JAWS. IT WAS NOTICED BEFORE USE. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT. INTERVENTION: USER USED HIS SECOND A3203 STEALTH CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841566 ↗
• MalfunctionApr 22, 2017Difficult to Open or Close; Difficult to Open or Close

  THE DOCTOR MENTIONED TO THE INSTRUMENT SPECIALIST THAT WHEN THE INSERT IS ATTACHED TO THE JAW, IT IS DIFFICULT FOR THE CLAMP TO MAINTAIN CLAPPED IN THE LOCKED POSITION. THE DOCTOR USED THE A0C02 INSERTS. APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION ON MARCH 14,2017 FROM THE CUSTOMER VIA PHONE: THE CUSTOMER HAS CONFIRMED THAT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNCLASP. IF THE HANDLE WERE TO BE TAPPED THE CLAMP WOULD RELEASE. PREVAC STEAM WAS USED TO STERILIZATION . PROCEDURE PERFORMED: UNK TYPE OF INTERVENTION: UNK PATIENT STATUS: THE CALLER WAS NOT INFORMED OF ANY PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6513676 ↗
• MalfunctionApr 22, 2017Difficult to Open or Close; Difficult to Open or Close

  THE DOCTOR MENTIONED TO THE INSTRUMENT SPECIALIST THAT WHEN THE INSERT IS ATTACHED TO THE JAW IT IS DIFFICULT FOR THE CLAMP TO MAINTAIN CLAPPED IN THE LOCKED POSITION. THE DOCTOR USED THE A0C02 INSERTS. APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION ON MARCH 14,2 017 FROM THE CUSTOMER VIA PHONE: THE CUSTOMER HAS CONFIRMED THAT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNCLASP. IF THE HANDLE WERE TO BE TAPPED THE CLAMP WOULD RELEASE. PREVAC STEAM WAS USED TO STERILIZATION. PROCEDURE PERFORMED: UNK. TYPE OF INTERVENTION: UNK. PATIENT STATUS: THE CALLER WAS NOT INFORMED OF ANY PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6513673 ↗
• MalfunctionApr 22, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  PROCEDURE PERFORMED: NA. THE CUSTOMER WAS TESTING THEIR CLAMPS AND IDENTIFIED THAT AT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNLOCK. TYPE OF INTERVENTION: NA. PATIENT STATUS: NA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6513667 ↗
• MalfunctionApr 22, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  PROCEDURE PERFORMED: NA. THE CUSTOMER WAS TESTING THEIR CLAMPS AND IDENTIFIED THAT AT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNLOCK. TYPE OF INTERVENTION: NA. PATIENT STATUS: NA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6513665 ↗
• MalfunctionApr 22, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  PROCEDURE PERFORMED: NA. THE CUSTOMER WAS TESTING THEIR CLAMPS AND IDENTIFIED THAT AT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNLOCK. TYPE OF INTERVENTION: NA. PATIENT STATUS: NA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6513664 ↗
• MalfunctionApr 22, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  PROCEDURE PERFORMED: NA. THE CUSTOMER WAS TESTING THEIR CLAMPS AND IDENTIFIED THAT AT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNLOCK. TYPE OF INTERVENTION: NA. PATIENT STATUS: NA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6513663 ↗
• MalfunctionApr 7, 2017Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: UNKNOWN - THE DOCTOR MENTIONED TO THE INSTRUMENT SPECIALIST THAT WHEN THE INSERT IS ATTACHED TO THE JAW IT IS DIFFICULT FOR THE CLAMP TO MAINTAIN CLAPPED IN THE LOCKED POSITION. THE DOCTOR USED THE A0C02 INSERTS. APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION ON MARCH 14,2017 FROM THE CUSTOMER VIA PHONE: THE CUSTOMER HAS CONFIRMED THAT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNCLASP. IF THE HANDLE WERE TO BE TAPPED THE CLAMP WOULD RELEASE. PREVAC STEAM WAS USED TO STERILIZATION. TYPE OF INTERVENTION: UNK. PATIENT STATUS: THE CALLER WAS NOT INFORMED OF ANY PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6474311 ↗
• MalfunctionApr 7, 2017Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: UNKNOWN - THE DOCTOR MENTIONED TO THE INSTRUMENT SPECIALIST THAT WHEN THE INSERT IS ATTACHED TO THE JAW IT IS DIFFICULT FOR THE CLAMP TO MAINTAIN CLAPPED IN THE LOCKED POSITION. THE DOCTOR USED THE A0C02 INSERTS. APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION ON MARCH 14,2017 FROM THE CUSTOMER VIA PHONE: THE CUSTOMER HAS CONFIRMED THAT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNCLASP. IF THE HANDLE WERE TO BE TAPPED THE CLAMP WOULD RELEASE. PREVAC STEAM WAS USED TO STERILIZATION TYPE OF INTERVENTION: UNK. PATIENT STATUS: THE CALLER WAS NOT INFORMED OF ANY PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6474310 ↗
• MalfunctionApr 5, 2017Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: UNKNOWN - THE DOCTOR MENTIONED TO THE INSTRUMENT SPECIALIST THAT WHEN THE INSERT IS ATTACHED TO THE JAW IT IS DIFFICULT FOR THE CLAMP TO MAINTAIN CLAPPED IN THE LOCKED POSITION. THE DOCTOR USED THE A0C02 INSERTS. APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION ON MARCH 14,2017 FROM THE CUSTOMER VIA PHONE: THE CUSTOMER HAS CONFIRMED THAT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNCLASP. IF THE HANDLE WERE TO BE TAPPED THE CLAMP WOULD RELEASE. PREVAC STEAM WAS USED TO STERILIZATION. ADDITIONAL CERS CREATED 2017-0423, 2017-0463, 2017-0464, 2017-0465, 2017-0466, 2017-0467, 2017-0468, 2017-0469, 2017-0470, 2017-0471, 2017-0472, 2017-0473, 2017-0474. TYPE OF INTERVENTION: UNK. PATIENT STATUS: THE CALLER WAS NOT INFORMED OF ANY PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6462520 ↗
• MalfunctionApr 5, 2017Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: UNKNOWN - THE DOCTOR MENTIONED TO THE INSTRUMENT SPECIALIST THAT WHEN THE INSERT IS ATTACHED TO THE JAW IT IS DIFFICULT FOR THE CLAMP TO MAINTAIN CLAPPED IN THE LOCKED POSITION. THE DOCTOR USED THE A0C02 INSERTS. APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION ON MARCH 14,2017 FROM THE CUSTOMER VIA PHONE: THE CUSTOMER HAS CONFIRMED THAT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNCLASP. IF THE HANDLE WERE TO BE TAPPED THE CLAMP WOULD RELEASE. PREVAC STEAM WAS USED TO STERILIZATION (B)(4). TYPE OF INTERVENTION: UNK. PATIENT STATUS: THE CALLER WAS NOT INFORMED OF ANY PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6462501 ↗
• MalfunctionApr 5, 2017Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: UNKNOWN - THE DOCTOR MENTIONED TO THE INSTRUMENT SPECIALIST THAT WHEN THE INSERT IS ATTACHED TO THE JAW IT IS DIFFICULT FOR THE CLAMP TO MAINTAIN CLAPPED IN THE LOCKED POSITION. THE DOCTOR USED THE A0C02 INSERTS. APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION ON MARCH 14,2017 FROM THE CUSTOMER VIA PHONE: THE CUSTOMER HAS CONFIRMED THAT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNCLASP. IF THE HANDLE WERE TO BE TAPPED THE CLAMP WOULD RELEASE. PREVAC STEAM WAS USED TO STERILIZATION ADDITIONAL CERS CREATED (B)(4). TYPE OF INTERVENTION: UNK. PATIENT STATUS: THE CALLER WAS NOT INFORMED OF ANY PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6462428 ↗
• MalfunctionApr 5, 2017Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: UNKNOWN - THE DOCTOR MENTIONED TO THE INSTRUMENT SPECIALIST THAT WHEN THE INSERT IS ATTACHED TO THE JAW IT IS DIFFICULT FOR THE CLAMP TO MAINTAIN CLAPPED IN THE LOCKED POSITION. THE DOCTOR USED THE A0C02 INSERTS. APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION ON MARCH 14,2017 FROM THE CUSTOMER VIA PHONE: THE CUSTOMER HAS CONFIRMED THAT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNCLASP. IF THE HANDLE WERE TO BE TAPPED THE CLAMP WOULD RELEASE. PREVAC STEAM WAS USED TO STERILIZATION. (B)(4). TYPE OF INTERVENTION: UNK. PATIENT STATUS: THE CALLER WAS NOT INFORMED OF ANY PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6462411 ↗
• MalfunctionApr 5, 2017Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: UNKNOWN - THE DOCTOR MENTIONED TO THE INSTRUMENT SPECIALIST THAT WHEN THE INSERT IS ATTACHED TO THE JAW IT IS DIFFICULT FOR THE CLAMP TO MAINTAIN CLAPPED IN THE LOCKED POSITION. THE DOCTOR USED THE A0C02 INSERTS. APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION ON MARCH 14,2017 FROM THE CUSTOMER VIA PHONE: THE CUSTOMER HAS CONFIRMED THAT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNCLASP. IF THE HANDLE WERE TO BE TAPPED THE CLAMP WOULD RELEASE. PREVAC STEAM WAS USED TO STERILIZATION. ADDITIONAL CERS CREATED (B)(4). TYPE OF INTERVENTION: UNK. PATIENT STATUS: THE CALLER WAS NOT INFORMED OF ANY PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6462355 ↗
• MalfunctionMar 30, 2017Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED UNKNOWN. THE DOCTOR MENTIONED TO THE INSTRUMENT SPECIALIST THAT WHEN THE INSERT IS ATTACHED TO THE JAW IT IS DIFFICULT FOR THE CLAMP TO MAINTAIN CLAPPED IN THE LOCKED POSITION. THE DOCTOR USED THE A0C02 INSERTS. APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION ON MARCH 14,2017 FROM THE CUSTOMER VIA PHONE: THE CUSTOMER HAS CONFIRMED THAT WHEN THE JAW IS CLAMPED CLOSED IT WOULD EASILY UNCLASP. IF THE HANDLE WERE TO BE TAPPED THE CLAMP WOULD RELEASE. PREVAC STEAM WAS USED TO STERILIZATION TYPE OF INTERVENTION: UNK. PATIENT STATUS: THE CALLER WAS NOT INFORMED OF ANY PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6446726 ↗