Soft/Traction Clamp Inserts A0801Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00607915113360), received between May 15, 2017 and Nov 29, 2017 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2017Material Separation; Material Separation

  PROCEDURE PERFORMED: UNKNOWN. INCIDENT DESCRIPTION: "THE TECH PLACED THE INSERTS INTO THE CLAMP. SHE HANDED THE CLAMP DIRECTLY TO THE SURGEON AND WHEN HE OPENED THE CLAMP THE INSERTS FELL OUT. THE TECH THEN PLACED ANOTHER SET OF INSERTS (FROM THE SAME LOT NUMBER) INTO THE CLAMP. THEY STAY IN THE CLAMP SECURELY." TYPE OF INTERVENTION: "THE TECH THEN PLACED ANOTHER SET OF INSERTS (FROM THE SAME LOT NUMBER) INTO THE CLAMP. THEY STAY IN THE CLAMP SECURELY." PATIENT STATUS: "PATIENT WAS NOT HARMED".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7068004 ↗
• MalfunctionMay 15, 2017Detachment Of Device Component; Detachment Of Device Component

  OPEN ANEURYSM REPAIR, FEM-POPLITEAL BYPASSES, CAROTID ENDARTERECTOMY - TODAY DURING A PROCEDURE OF SCRUB NURSE TOLD ME THAT WHEN THE FOGARTY CLAMP WAS OPENED BY MD THE INSERTS WERE ATTACHED TOGETHER RATHER THAN STAYING ON EACH SIDE OF THE CLAMP. THE LIGHT BLUE INSERT IS WHAT SEEMS TO BE THE ISSUE. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NOT AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6567348 ↗
• MalfunctionMay 15, 2017Detachment Of Device Component; Detachment Of Device Component

  OPEN ANEURYSM REPAIR, FEM-POPLITEAL BYPASSES, CAROTID ENDARTERECTOMY - TODAY DURING A PROCEDURE OF SCRUB NURSE TELLING ME THAT WHEN THE FOGARTY CLAMP WAS OPENED BY MD THE INSERTS WERE ATTACHED TOGETHER RATHER THAN STAYING ON EACH SIDE OF THE CLAMP. THE LIGHT BLUE INSERT IS WHAT SEEMS TO BE THE ISSUE. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NOT AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6567346 ↗
• MalfunctionMay 15, 2017Detachment Of Device Component; Detachment Of Device Component

  OPEN ANEURYSM REPAIR, FEM-POPLITEAL BYPASSES, CAROTID ENDARTERECTOMY - TODAY DURING A PROCEDURE OF SCRUB NURSE TELLING ME THAT WHEN THE FOGARTY CLAMP WAS OPENED BY MD THE INSERTS WERE ATTACHED TOGETHER RATHER THAN STAYING ON EACH SIDE OF THE CLAMP. THE LIGHT BLUE INSERT IS WHAT SEEMS TO BE THE ISSUE. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NOT AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6567345 ↗
• MalfunctionMay 15, 2017Detachment Of Device Component; Detachment Of Device Component

  OPEN ANEURYSM REPAIR, FEM-POPLITEAL BYPASSES, CAROTID ENDARTERECTOMY - TODAY DURING A PROCEDURE OF SCRUB NURSE TELLING ME THAT WHEN THE FOGARTY CLAMP WAS OPENED BY MD THE INSERTS WERE ATTACHED TOGETHER RATHER THAN STAYING ON EACH SIDE OF THE CLAMP. THE LIGHT BLUE INSERT IS WHAT SEEMS TO BE THE ISSUE. TYPE OF INTERVENTION: UNKNOWN PATIENT STATUS: NOT AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6567344 ↗
• MalfunctionMay 15, 2017Detachment Of Device Component; Detachment Of Device Component

  OPEN ANEURYSM REPAIR, FEM-POPLITEAL BYPASSES, CAROTID ENDARTERECTOMY - TODAY DURING A PROCEDURE OF SCRUB NURSE TELLING ME THAT WHEN THE FOGARTY CLAMP WAS OPENED BY MD THE INSERTS WERE ATTACHED TOGETHER RATHER THAN STAYING ON EACH SIDE OF THE CLAMP. THE LIGHT BLUE INSERT IS WHAT SEEMS TO BE THE ISSUE. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NOT AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6567342 ↗
• MalfunctionMay 15, 2017Detachment Of Device Component; Detachment Of Device Component

  OPEN ANEURYSM REPAIR, FEM-POPLITEAL BYPASSES, CAROTID ENDARTERECTOMY - "FALLS APART DURING PROCEDURE" APPLIED MEDICAL RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER ON MAY 2, 2017 VIA EMAIL. THE LIGHT BLUE INSERT IS THE COMPONENT THAT DETACHED, IT DID NOT FALL INTO PATIENT, BUT ONTO STERILE FIELD PRIOR TO HANDING TO MD. THE CUSTOMER WAS NOT INFORMED BY THE STAFF THAT THE USER EXPERIENCED LOSS OF OCCLUSION, JUST THAT INSERTS ARE NOT STAYING IN THE CLAMP. THE INSERT WAS USED WITH FOGARTY ARTERIAL CLAMPS ANGLED AND STRAIGHT. THE INSERT COME IN CONTACT WITH ANY SHARP INSTRUMENTS AND APPEARED TO BE INTACT. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NOT AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6567341 ↗