STEALTH® CLAMP INSERTS A0A13Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915113001), received between Feb 13, 2026 and Feb 25, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Device Slipped

  PROCEDURE PERFORMED: DESCENDING THORACIC AORTA TO BILATERAL FEMORAL BYPASS. EVENT DESCRIPTION: I AM FROM "[HOSPITAL]" IN (B)(6). ONE OF OUR SURGEONS REALLY LIKES THE AORTIC STEALTH CLAMPS, HOWEVER THE CLAMP INSERTS ARE QUITE SLIPPERY AND HAVE ACTUALLY COME OFF THE AORTA A FEW DIFFERENT TIMES. DO YOU HAVE A MORE 'STICKY' INSERT THAT WILL NOT SLIDE OFF OF THE AORTA? HE IS USING THEM CORRECTLY. ARE OTHER HOSPITALS REPORTING THIS PROBLEM? HE HAS UNFORTUNATELY, STOPPED USING THEM AS HE CANNOT RISK THEM SLIDING DURING THE PROCEDURE. THREE DEVICE MALFUNCTIONS OCCURRED DURING THREE DIFFERENT PROCEDURES. THE SAME DOCTOR EXPERIENCED THE ISSUE THREE TIMES. IT HAPPENED A COUPLE OF TIMES, THE RUBBER DOESN'T GRIP THE TISSUE THE WHOLE CLAMP FALLS OFF THE AORTA. THE TYPE OF INSERT TYPICALLY USED IS STEALTH INSERT. THERE WAS NO SEPARATION OF THE INSERT PAD FROM THE BASE. ADDITIONAL INFORMATION PROVIDED BY "[NAME]" ON (B)(6) 2026 BY EMAIL: I HAVE THE REFERENCE NUMBER FOR THE STEALTH INSERTS, AND IT IS A0A13. ARE OTHER FACILITIES HAVING THESE SAME ISSUES? IT IS ALMOST LIKE THE RUBBER IS TOO SLIPPERY TO GRIP THE AORTA ADEQUATELY. WE USED A DIFFERENT CLAMP TO RESOLVE THE CASE. EACH TIME, IT HAS BEEN SL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24447506 ↗
• MalfunctionFeb 25, 2026Device Slipped

  PROCEDURE PERFORMED: DESCENDING THORACIC AORTA TO BILATERAL FEMORAL BYPASS. EVENT DESCRIPTION: I AM FROM "[HOSPITAL]" IN (B)(6). ONE OF OUR SURGEONS REALLY LIKES THE AORTIC STEALTH CLAMPS, HOWEVER THE CLAMP INSERTS ARE QUITE SLIPPERY AND HAVE ACTUALLY COME OFF THE AORTA A FEW DIFFERENT TIMES. DO YOU HAVE A MORE 'STICKY' INSERT THAT WILL NOT SLIDE OFF OF THE AORTA? HE IS USING THEM CORRECTLY. ARE OTHER HOSPITALS REPORTING THIS PROBLEM? HE HAS UNFORTUNATELY, STOPPED USING THEM AS HE CANNOT RISK THEM SLIDING DURING THE PROCEDURE. THREE DEVICE MALFUNCTIONS OCCURRED DURING THREE DIFFERENT PROCEDURES. THE SAME DOCTOR EXPERIENCED THE ISSUE THREE TIMES. IT HAPPENED A COUPLE OF TIMES, THE RUBBER DOESN'T GRIP THE TISSUE THE WHOLE CLAMP FALLS OFF THE AORTA. THE TYPE OF INSERT TYPICALLY USED IS STEALTH INSERT. THERE WAS NO SEPARATION OF THE INSERT PAD FROM THE BASE. ADDITIONAL INFORMATION PROVIDED BY "[NAME]" ON 28JAN2026 BY EMAIL: I HAVE THE REFERENCE NUMBER FOR THE STEALTH INSERTS, AND IT IS A0A13. ARE OTHER FACILITIES HAVING THESE SAME ISSUES? IT IS ALMOST LIKE THE RUBBER IS TOO SLIPPERY TO GRIP THE AORTA ADEQUATELY. WE USED A DIFFERENT CLAMP TO RESOLVE THE CASE. EACH TIME, IT HAS BEEN SLIP

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24447484 ↗
• MalfunctionFeb 13, 2026Device Slipped

  PROCEDURE PERFORMED: DESCENDING THORACIC AORTA TO BILATERAL FEMORAL BYPASS EVENT DESCRIPTION: I AM FROM "[HOSPITAL]" IN (B)(6). ONE OF OUR SURGEONS REALLY LIKES THE AORTIC STEALTH CLAMPS, HOWEVER THE CLAMP INSERTS ARE QUITE SLIPPERY AND HAVE ACTUALLY COME OFF THE AORTA A FEW DIFFERENT TIMES. DO YOU HAVE A MORE 'STICKY' INSERT THAT WILL NOT SLIDE OFF OF THE AORTA? HE IS USING THEM CORRECTLY. ARE OTHER HOSPITALS REPORTING THIS PROBLEM? HE HAS UNFORTUNATELY, STOPPED USING THEM AS HE CANNOT RISK THEM SLIDING DURING THE PROCEDURE. THREE DEVICE MALFUNCTIONS OCCURRED DURING THREE DIFFERENT PROCEDURES. THE SAME DOCTOR EXPERIENCED THE ISSUE THREE TIMES. IT HAPPENED A COUPLE OF TIMES, THE RUBBER DOESN'T GRIP THE TISSUE THE WHOLE CLAMP FALLS OFF THE AORTA. THE TYPE OF INSERT TYPICALLY USED IS STEALTH INSERT. THERE WAS NO SEPARATION OF THE INSERT PAD FROM THE BASE. ADDITIONAL INFORMATION PROVIDED BY "[NAME]" ON 28JAN2026 BY EMAIL: I HAVE THE REFERENCE NUMBER FOR THE STEALTH INSERTS, AND IT IS A0A13. ARE OTHER FACILITIES HAVING THESE SAME ISSUES? IT IS ALMOST LIKE THE RUBBER IS TOO SLIPPERY TO GRIP THE AORTA ADEQUATELY. WE USED A DIFFERENT CLAMP TO RESOLVE THE CASE. EACH TIME, IT HAS BEEN SLIPP

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24338686 ↗