Stealth® Clamps A3213Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00607915112691), received between Mar 9, 2016 and May 16, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Material Twisted/Bent; Patient Device Interaction Problem; Material Twisted/Bent; Patient Device Interaction Problem

  PROCEDURE PERFORMED: AORTIC CLAMPING. EVENT DESCRIPTION: STEALTH CLAMP SCISSORS DURING AORTIC CLAMPING. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039767 ↗
• MalfunctionJan 20, 2025Material Twisted/Bent; Patient Device Interaction Problem; Material Twisted/Bent; Patient Device Interaction Problem

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: HOSPITAL: [HOSPITAL NAME]: COMPLAINT 1 OF 3: (B)(4), COMPLAINT 2 OF 3: (B)(4), COMPLAINT 3 OF 3: (B)(4). THE PRODUCT DID NOT WORK AS IT SHOULD. WHEN THE CLOSING MOVEMENT IS MADE, THE ENDS DO NOT MATCH. SEE PICTURES FOR MORE DETAIL. NO PATIENT WAS INVOLVED AS IT WAS DETECTED PRIOR TO SURGERY. TYPE OF INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21193648 ↗
• MalfunctionJan 20, 2025Material Twisted/Bent; Failure to Seal; Material Twisted/Bent; Failure to Seal

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: HOSPITAL: [HOSPITAL NAME]: COMPLAINT 1 OF 3: (B)(4), COMPLAINT 2 OF 3: (B)(4), COMPLAINT 3 OF 3: (B)(4). THE PRODUCT DID NOT WORK AS IT SHOULD. WHEN THE CLOSING MOVEMENT IS MADE, THE ENDS DO NOT MATCH. SEE PICTURES FOR MORE DETAIL. NO PATIENT WAS INVOLVED AS IT WAS DETECTED PRIOR TO SURGERY. TYPE OF INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21193255 ↗
• MalfunctionJan 17, 2025Material Twisted/Bent; Failure to Seal; Material Twisted/Bent; Failure to Seal

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: HOSPITAL: [HOSPITAL NAME] COMPLAINT 1 OF 3: (B)(4). COMPLAINT 2 OF 3: (B)(4). COMPLAINT 3 OF 3: (B)(4). THE PRODUCT DID NOT WORK AS IT SHOULD. WHEN THE CLOSING MOVEMENT IS MADE, THE ENDS DO NOT MATCH. SEE PICTURES FOR MORE DETAIL. NO PATIENT WAS INVOLVED AS IT WAS DETECTED PRIOR TO SURGERY. TYPE OF INTERVENTION: NI PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179973 ↗
• MalfunctionJun 27, 2024Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  PROCEDURE PERFORMED: [NI] EVENT DESCRIPTION: [HOSPITAL: [HOSPITAL NAME] PRODUCT: A3213 COMPLAINT 1 OF 4: (B)(4) MODEL #A3213 LOT # UNKNOWN COMPLAINT 2 OF 4: (B)(4) MODEL #A3213 LOT # UNKNOWN COMPLAINT 3 OF 4: (B)(4) MODEL #A3213 LOT # UNKNOWN COMPLAINT 4 OF 4: (B)(4) MODEL #A3213 LOT # UNKNOWN. [HOSPITAL NAME] THE CARDIOVASCULAR SURGEON STOPPED THE REP IN THE MIDDLE OF THE HOSPITAL HALLWAY TO STATE THAT THEY HAD SOME CLAMPS THAT WERE SCISSORING AT THE TIPS. NO SPECIFIC EVENT/CASE WAS MENTIONED. THE REP INSPECTED THE HOSPITAL'S SEVEN CLAMPS, AND FOUND THAT FOUR OF THE CLAMPS WERE LOOSE. THERE WAS NO LOSS OF OCCLUSION WHEN USING THE CLAMPS, THE SURGEON JUST HAD TO BE MORE VIGILANT. IN ONE CASE, HE REPLACED A CLAMP WITH A NEW ONE. THERE ARE NO PATIENT INJURIES INVOLVED WITH THIS COMPLAINT. INSERTS WERE ABLE TO BE ATTACHED TO THE CLAMPS. THE INSERTS WOULD NOT FALL OFF, BUT THEY WOULD MISALIGN DUE TO THE CLAMP SCISSORING. THE LOT NUMBERS ARE UNKNOWN. THE PRODUCT IS AVAILABLE FOR RETURN.] TYPE OF INTERVENTION: [SURGEON WOULD USE A NEW CLAMP IF NEEDED.] PATIENT STATUS [NO PATIENT INJURY.].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630183 ↗
• MalfunctionJun 27, 2024Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  PROCEDURE PERFORMED: [NI] EVENT DESCRIPTION: [HOSPITAL: [HOSPITAL NAME], PRODUCT: A3213, COMPLAINT 1 OF 4: 2024-001553 MODEL #A3213 LOT # UNKNOWN, COMPLAINT 2 OF 4: 2024-001554 MODEL #A3213 LOT # UNKNOWN, COMPLAINT 3 OF 4: 2024-001555 MODEL #A3213 LOT # UNKNOWN, COMPLAINT 4 OF 4: 2024-001556 MODEL #A3213 LOT # UNKNOWN. [HOSPITAL NAME] THE CARDIOVASCULAR SURGEON STOPPED THE REP IN THE MIDDLE OF THE HOSPITAL HALLWAY TO STATE THAT THEY HAD SOME CLAMPS THAT WERE SCISSORING AT THE TIPS. NO SPECIFIC EVENT/CASE WAS MENTIONED. THE REP INSPECTED THE HOSPITAL'S SEVEN CLAMPS, AND FOUND THAT FOUR OF THE CLAMPS WERE LOOSE. THERE WAS NO LOSS OF OCCLUSION WHEN USING THE CLAMPS, THE SURGEON JUST HAD TO BE MORE VIGILANT. IN ONE CASE, HE REPLACED A CLAMP WITH A NEW ONE. THERE ARE NO PATIENT INJURIES INVOLVED WITH THIS COMPLAINT. INSERTS WERE ABLE TO BE ATTACHED TO THE CLAMPS. THE INSERTS WOULD NOT FALL OFF, BUT THEY WOULD MISALIGN DUE TO THE CLAMP SCISSORING. THE LOT NUMBERS ARE UNKNOWN. THE PRODUCT IS AVAILABLE FOR RETURN.] TYPE OF INTERVENTION: [SURGEON WOULD USE A NEW CLAMP IF NEEDED.] PATIENT STATUS [NO PATIENT INJURY.]

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630175 ↗
• MalfunctionJun 27, 2024Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  PROCEDURE PERFORMED: (B)(6). EVENT DESCRIPTION: PRODUCT: A3213. COMPLAINT 1 OF 4: (B)(4) MODEL #A3213 LOT # 1480187, 1EA. COMPLAINT 2 OF 4: (B)(4) MODEL #A3213 LOT # 1480187, 1EA. COMPLAINT 3 OF 4: (B)(4) MODEL #A3213 LOT # 1457736 ,1EA. COMPLAINT 4 OF 4: (B)(4) MODEL #A3213 LOT # 1457736 ,1EA. THE CARDIOVASCULAR SURGEON STOPPED THE REP IN THE MIDDLE OF THE HOSPITAL HALLWAY TO STATE THAT THEY HAD SOME CLAMPS THAT WERE SCISSORING AT THE TIPS. NO SPECIFIC EVENT/CASE WAS MENTIONED. THE REP INSPECTED THE HOSPITAL'S SEVEN CLAMPS, AND FOUND THAT FOUR OF THE CLAMPS WERE LOOSE. THERE WAS NO LOSS OF OCCLUSION WHEN USING THE CLAMPS, THE SURGEON JUST HAD TO BE MORE VIGILANT. IN ONE CASE, HE REPLACED A CLAMP WITH A NEW ONE. THERE ARE NO PATIENT INJURIES INVOLVED WITH THIS COMPLAINT. INSERTS WERE ABLE TO BE ATTACHED TO THE CLAMPS. THE INSERTS WOULD NOT FALL OFF, BUT THEY WOULD MISALIGN DUE TO THE CLAMP SCISSORING. THE LOT NUMBERS ARE UNKNOWN. THE PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: SURGEON WOULD USE A NEW CLAMP IF NEEDED. PATIENT STATUS. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630167 ↗
• MalfunctionJun 24, 2024Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  PROCEDURE PERFORMED: [NI] EVENT DESCRIPTION: [HOSPITAL: [HOSPITAL NAME] PRODUCT: A3213 COMPLAINT 1 OF 4: (B)(4) MODEL #A3213 LOT # UNKNOWN COMPLAINT 2 OF 4:(B) (4) MODEL #A3213 LOT # UNKNOWN COMPLAINT 3 OF 4: (B)(4) MODEL #A3213 LOT # UNKNOWN COMPLAINT 4 OF 4:(B)(4) MODEL #A3213 LOT # UNKNOWN [HOSPITAL NAME] THE CARDIOVASCULAR SURGEON STOPPED THE REP IN THE MIDDLE OF THE HOSPITAL HALLWAY TO STATE THAT THEY HAD SOME CLAMPS THAT WERE SCISSORING AT THE TIPS. NO SPECIFIC EVENT/CASE WAS MENTIONED. THE REP INSPECTED THE HOSPITAL'S SEVEN CLAMPS AND FOUND THAT FOUR OF THE CLAMPS WERE LOOSE. THERE WAS NO LOSS OF OCCLUSION WHEN USING THE CLAMPS, THE SURGEON JUST HAD TO BE MORE VIGILANT. IN ONE CASE, HE REPLACED A CLAMP WITH A NEW ONE. THERE ARE NO PATIENT INJURIES INVOLVED WITH THIS COMPLAINT. INSERTS WERE ABLE TO BE ATTACHED TO THE CLAMPS. THE INSERTS WOULD NOT FALL OFF, BUT THEY WOULD MISALIGN DUE TO THE CLAMP SCISSORING. THE LOT NUMBERS ARE UNKNOWN. THE PRODUCT IS AVAILABLE FOR RETURN.] TYPE OF INTERVENTION: [SURGEON WOULD USE A NEW CLAMP IF NEEDED.] PATIENT STATUS [NO PATIENT INJURY.]

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19602229 ↗
• MalfunctionJan 19, 2022Failure to Align; Failure to Align

  PROCEDURE PERFORMED: AORTA OPERATION. EVENT DESCRIPTION: TIPS OF CLAMPS ARE SOME HOW "TIRED" DURING OPERATION TIPS WERE LIKE CROSSED WITH INSERTS. IT CAN CAUSE PROBLEMS TO PATIENT DURING OPERATION. THE USER TOOK ANOTHER CLAMP. CLAMP IS STILL IN HOSPITAL. I AM WAITING FOR INSTRUCTIONS HOW TO PROCEED WITH THIS ISSUE. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 31DEC2021: PRODUCT IS ABLE TO BE RETURNED FOR EVALUATION. YES, THE SURGEON DID EXPERIENCE LOSS OF OCCLUSION DUE TO JAW SEPARATION. NO DAMAGE TO THE VESSEL. DEVICE WAS RESTERILIZED BEFORE USE. NO RUST NOTED ON THE DEVICE. NO EXPERIENCE OF INSERT DETACHMENT DURING USE. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 4-MAY-2022: THE HOSPITAL DOES NOT HAVE ANY ADDITIONAL BROKEN INSTRUMENTS. TYPE OF INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13295906 ↗
• MalfunctionFeb 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN, BUT A CARDIAC SURGERY. FROM INITIAL NOTIFICATION: I RECEIVED A DEFECTIVE APPLIED FORCEPS A3213 FROM THE OPERATING ROOM. THIS IS TORN AT THE HINGE. ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE BY EMAIL ON 24JAN2019: DO YOU HAVE THE LOT NUMBER OF THE INSTRUMENT? LOT NUMBER IS 1295988. HOW DID THE INSTRUMENT TEAR? BEFORE, DURING OR AFTER USE? OR DURING CLEANING? DURING. IF DURING USE, CAN YOU INDICATE DURING WHICH PROCEDURE? NOT SPECIFICALLY BUT DURING A CARDIAC PROCEDURE. IS IT ONLY TORN OR DID A PIECE BREAK OFF? DO YOU PERHAPS HAVE A PHOTO? TEAR. PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8337755 ↗
• MalfunctionMar 6, 2017Mechanical Problem; Mechanical Problem

  PROCEDURE PERFORMED UNKNOWN - "(ON (B)(6) 2017: DURING PROCEDURE) RATCHETS OF THE CLAMP A3213 WERE DISENGAGED DURING A PROCEDURE. THE RATCHETS PAWLS DIDN'T ENGAGE TO THE OTHER SIDE PROPERLY. MEDICAL STAFF CONFIRMED THAT THE RATCHET PAWLS DIDN'T MATCH EACH OTHER PROPERLY WHILE PREPARING THE PROCEDURE. THIS DIDN'T AFFECT THE PATIENT." TYPE OF INTERVENTION: UNK. PATIENT STATUS: NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6380723 ↗
• MalfunctionMar 1, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  AORTIC VALVE SUBSTITUTION - "THE CLAMP DOESN'T CLOSE THE JAWS PROPERLY. WE HAD ALREADY SENT A PRODUCT REPLACEMENT. THE CUSTOMER IS NOT WAITING FOR ANY FURTHER ACTION, UNLESS THE PICKUP OF THE PRODUCT BY THE COURIER. WHEN WE'LL HAVE THE PRODUCT, WE'LL SEND BACK TO THE OFFICE FOR INSPECTION FOR OUR INTERNAL RECORDS." TYPE OF INTERVENTION - "N/A." PATIENT STATUS - "GOOD."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6368584 ↗
• MalfunctionMar 9, 2016Positioning Failure; Positioning Failure

  VALVOLA AORTICA E BYPASS- "DURING OPERATION IT DOESN'T CLOSE PROPERLY THE JAWS. WE HAVEN'T HAD THE OPPORTUNITY TO SEE THE CLAMP, SO THE DESCRIPTION OF THE EVENT HAS BEEN REPORTED BY THE HEAD NURSE. WE NEED TO GO TO THE CUSTOMER TO VERIFY MORE DEEPLY WHAT WAS THE PROBLEM AND IF THE ISSUE WAS CAUSED BY A MISFUNCTION OF THE CLAMP OR BY AN IMPROPER USAGE OF THE CUSTOMER." PATIENT STATUS - "GOOD."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5491220 ↗
• MalfunctionMar 9, 2016Positioning Failure; Positioning Failure

  VALVOLA AORTICA- "DURING OPERATION, IT DOESN'T CLOSE PROPERLY THE JAWS. WE HAVEN'T HAD THE OPPORTUNITY TO SEE THE CLAMP, SO THE DESCRIPTION OF THE EVENT HAS BEEN REPORTED BY THE HEAD NURSE. WE NEED TO GO TO THE CUSTOMER TO VERIFY MORE DEEPLY WHAT WAS THE PROBLEM AND IF THE ISSUE WAS CAUSED BY A MISFUNCTION OF THE CLAMP OR BY AN IMPROPER USAGE OF THE CUSTOMER." PATIENT STATUS - "GOOD."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5490642 ↗