STEALTH® FIBRA® CLAMP INSERT A0G01Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00607915114725), received between Mar 6, 2017 and Feb 6, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: [CARDIAC SURGERY] EVENT DESCRIPTION: [HOSPITAL: [HOSPITAL NAME] DISTRIBUTOR: [DISTRIBUTOR NAME] MODEL #: A0G01. LOT #: 1510129. THE PROCEDURE WAS CARDIAC SURGERY. WHILE USING THE INSERTS TO BLOCK BLOOD FLOW, THE RUBBER PART OF THE INSERTS DETACHED FROM THE PRODUCT. THE SURGEON DID NOT NOTICE ANYTHING WRONG DURING THE SETUP OR WHEN IT STARTED TO BE USED. HOWEVER, THE DETACHMENT WAS DISCOVERED LATER DURING ITS USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING THE INSERT CONTINUOUSLY. THE PRODUCT IN QUESTION WAS RETURNED FROM THE HOSPITAL. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE. THE HOSPITAL HAS REQUESTED THE INVESTIGATION REPORT. ADDITIONAL INFORMATION OBTAINED FROM APPLIED MEDICAL REP VIA EMAIL ON 27JAN2025: NO OTHER DEVICES OR INSTRUMENTS WERE USED. THE SURGICAL TEAM NOTICED DURING AORTIC CLAMPING THAT THE DEVICE MALFUNCTIONED. THE INSERT PAD PARTIALLY DETACHED FROM THE INSERT. THE PAD DID NOT FALL INTO THE PATIENT'S BODY. THERE WAS NO DAMAGE TO THE VESSEL. THE SURGEON NOTICED SOMETHING UNUSUAL WHILE USING THE INSERT, WHICH LED TO THE IDENTIFICATION OF A MALFUNCTION. TYPE OF INTERVENTION: [THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING THE INSERT CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324176 ↗
• MalfunctionMar 7, 2024Fracture; Fracture

  PROCEDURE PERFORMED: CARDIAC SURGERY. EVENT DESCRIPTION: ON (B)(6) 2024. [PROCEDURE: CARDIAC SURGERY] WHEN IT WAS OPENED, NURSE NOTICED THAT THE INSERT IN QUESTION WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM BY USING ANOTHER A0G01. COMPLAINT SAMPLE WILL BE RETURNED FROM THE HOSPITAL. PRODUCTS TO BE RETURNED: 1 INSERT. ADDITIONAL INFORMATION VIA EMAIL ON 8JAN2024: THIS INSERT WAS NOT ACTUALLY USED IN THE SURGERY BECAUSE THE DAMAGE WAS NOTICED WHEN THE POUCH WAS OPENED. THEREFORE, OTHER A0G01 WAS USED FOR THE SURGERY AND IT WAS COMPLETED WITH NO PROBLEM. IN ADDITION, THE INSERT DID NOT ENCOUNTER ANY SHARP INSTRUMENTS DURING THE PROCEDURE. TYPE OF INTERVENTION: THE PROCEDURE WAS COMPLETED WITH NO PROBLEM BY USING ANOTHER A0G01. PATIENT STATUS: NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862587 ↗
• MalfunctionMar 6, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  FEMORAL/TIBIAL FIXATION - "DURING DR. (B)(6) FEM/TIB PROCEDURE THIS MORNING, THEY OPENED THE INSERT AND NOTICED THAT THE RUBBER PORTION OF THE INSERT WAS COMING OFF. THEY OPENED 7-8 OF THE SAME LOT NUMBER AND THEY WERE ALL THE SAME. WE HAVE PULLED THE ENTIRE LOT OFF OF OUR SHELVES." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6382263 ↗
• MalfunctionMar 6, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  FEMORAL/TIBIAL FIXATION- "DURING DR. (B)(6)'S FEM/TIB PROCEDURE THIS MORNING, THEY OPENED THE INSERT AND NOTICED THAT THE RUBBER PORTION OF THE INSERT WAS COMING OFF. THEY OPENED 7-8 OF THE SAME LOT NUMBER AND THEY WERE ALL THE SAME. WE HAVE PULLED THE ENTIRE LOT OFF OF OUR SHELVES." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6382262 ↗
• MalfunctionMar 6, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  FEMORAL/TIBIAL FIXATION- "DURING DR. (B)(6) FEM/TIB PROCEDURE THIS MORNING, THEY OPENED THE INSERT AND NOTICED THAT THE RUBBER PORTION OF THE INSERT WAS COMING OFF. THEY OPENED 7-8 OF THE SAME LOT NUMBER AND THEY WERE ALL THE SAME. WE HAVE PULLED THE ENTIRE LOT OFF OF OUR SHELVES." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6382259 ↗
• MalfunctionMar 6, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  FEMORAL/TIBIAL FIXATION- "DURING DR. (B)(6) FEM/TIB PROCEDURE THIS MORNING, THEY OPENED THE INSERT AND NOTICED THAT THE RUBBER PORTION OF THE INSERT WAS COMING OFF. THEY OPENED 7-8 OF THE SAME LOT NUMBER AND THEY WERE ALL THE SAME. WE HAVE PULLED THE ENTIRE LOT OFF OF OUR SHELVES." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6382257 ↗
• MalfunctionMar 6, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  FEMORAL/TIBIAL FIXATION- "DURING DR. (B)(6)'S FEM/TIB PROCEDURE THIS MORNING, THEY OPENED THE INSERT AND NOTICED THAT THE RUBBER PORTION OF THE INSERT WAS COMING OFF. THEY OPENED 7-8 OF THE SAME LOT NUMBER AND THEY WERE ALL THE SAME. WE HAVE PULLED THE ENTIRE LOT OFF OF OUR SHELVES." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6382256 ↗
• MalfunctionMar 6, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  FEMORAL/TIBIAL FIXATION- "DURING DR. (B)(6)'S FEM/TIB PROCEDURE THIS MORNING, THEY OPENED THE INSERT AND NOTICED THAT THE RUBBER PORTION OF THE INSERT WAS COMING OFF. THEY OPENED 7-8 OF THE SAME LOT NUMBER AND THEY WERE ALL THE SAME. WE HAVE PULLED THE ENTIRE LOT OFF OF OUR SHELVES." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6382255 ↗
• MalfunctionMar 6, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  FEMORAL/TIBIAL FIXATION- "DURING DR. (B)(6)'S FEM/TIB PROCEDURE THIS MORNING, THEY OPENED THE INSERT AND NOTICED THAT THE RUBBER PORTION OF THE INSERT WAS COMING OFF. THEY OPENED 7-8 OF THE SAME LOT NUMBER AND THEY WERE ALL THE SAME. WE HAVE PULLED THE ENTIRE LOT OFF OF OUR SHELVES." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6382253 ↗
• MalfunctionMar 6, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  FEMORAL/TIBIAL FIXATION- "DURING DR. (B)(6)'S FEM/TIB PROCEDURE THIS MORNING, THEY OPENED THE INSERT AND NOTICED THAT THE RUBBER PORTION OF THE INSERT WAS COMING OFF. THEY OPENED 7-8 OF THE SAME LOT NUMBER AND THEY WERE ALL THE SAME. WE HAVE PULLED THE ENTIRE LOT OFF OF OUR SHELVES." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6382252 ↗