SOFT / FIBRA® CLAMP INSERT G-8650Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00607915111281), received between Aug 16, 2016 and Mar 30, 2026 — classified as 7 malfunctions.

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

• MalfunctionMar 30, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: AORTIC VALVE REPLACEMENT EVENT DESCRIPTION: IT WAS IDENTIFIED DURING AORTIC BLOCKADE. THERE WAS NO CLINICAL IMPACT TO THE PATIENT. WHILE THE INSERT WAS BEING USED FOR AORTIC BLOCKADE, IT WAS IDENTIFIED THAT THE RUBBER PART OF THE PRODUCT DETACHED FROM THE PRODUCT BY THE SURGEON. THE DETACHMENT DID NOT AFFECT THE BLOCKADE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE CONTINUOUS USE OF THE INSERT. THE PRODUCT IN QUESTION WILL BE RETURNED TO YOU FOR YOUR INVESTIGATION. ADDITIONAL INFORMATION PROVIDED ON 25FEB2026: ONE UNIT MALFUNCTIONED. THE DETACHMENT WAS ONLY PARTIAL. SO, THE INSERT DIDN'T FALL OFF. INTERVENTION: THE DEVICE WAS USED CONTINUOUSLY. PATIENT STATUS: THIS EVENT DIDN'T AFFECT THE PROCEDURE, WHICH MEANS THE PATIENT WASN'T AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729894 ↗
• MalfunctionJun 25, 2021Break; Break

  TYPE OF PROCEDURE PERFORMED: CARDIAC SURGERY. HOSPITAL: [NAME] "(B)(4). ON (B)(6) 2021: DURING CORONARY ARTERY BYPASS GRAFTING DURING CLAMPING THE VESSEL, THE SURGEON REPLACED THE INSERT IN QUESTION TO ANOTHER NEW ONE BECAUSE IT WAS UNUSUAL. IT WAS FOUND THE INSERT IN QUESTION WAS BROKEN AFTER THE SURGERY. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM, AND NO ADVERSE EVENT OCCURRED. THE SURGEON USED THE CLAMP MANUFACTURED BY AMR WITH THE INSERT IN QUESTION. THE SEPARATED PAD AT DAMAGED SECTION WAS CUT BY THE SURGEON PROBABLY, HOWEVER NO FURTHER INFORMATION PROVIDED FROM THE HOSPITAL." COMMENTS FROM COSMOTEC: THE HOSPITAL RETURNED THE COMPLAINT SAMPLE AND WILL BE RETURNED TO APPLIED MEDICAL TO INVESTIGATE. INVESTIGATION REPORT FOR THIS CASE IS REQUIRED AS SOON AS POSSIBLE. TYPE OF INTERVENTION: REPLACED THE INSERT IN QUESTION TO ANOTHER NEW ONE. PATIENT STATUS: NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071678 ↗
• MalfunctionJun 27, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  PROCEDURE PERFORMED: UNSPECIFIED CARDIOVASCULAR SURGERY. INCIDENT DESCRIPTION: "GEOMED CLAMP WAS USED TO ATTACH THE INSERT G8650. A MEDICAL STAFF TRIED TO CLAMP THE PATIENT'S VESSEL. AT THAT TIME, THE MEDICAL STAFF FOUND THAT THE INSERT WOBBLED A LITTLE, BUT THE MEDICAL STAFF ELECTED TO USE THE INSERT. WHEN THE MEDICAL STAFF TRIED TO REMOVE THE CLAMP FROM THE PATIENT VESSEL, THE MEDICAL STAFF FOUND THAT ONE OF THE ATTACHMENT BUTTON OF THE INSERT WAS MISSING. THE MEDICAL STAFF THOUGHT THAT THE ATTACHMENT BUTTON WAS FALLEN INTO THE PATIENT BODY. AT THE END, THE MISSING ATTACHMENT BUTTON WAS RECOVERED BY CELL SAVER® (BLOOD RECOVERY SYSTEM). THIS EVENT DIDN'T AFFECT THE PATIENT." TYPE OF INTERVENTION: NA. PATIENT STATUS: "NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6672009 ↗
• MalfunctionMar 6, 2017Fitting Problem; Fitting Problem

  PROCEDURE PERFORMED UNKNOWN - "(ON (B)(6) 2017: DURING PROCEDURE) A MEDICAL STAFF ATTACHED THE INSERT TO A CLAMP AND THE MEDICAL STAFF BROUGHT IT TO AN OPERATIVE FIELD. A PHYSICIAN CONFIRMED THE DEVICE AND IT WAS FOUND THAT THE INSERT WAS NOT ATTACHED TO THE CLAMP SECURELY. ANOTHER PACKAGE OF THE INSERT WAS USED FOR PROCEDURE. THIS EVENT DIDN'T AFFECT THE PATIENT." PATIENT STATUS: NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6380745 ↗
• MalfunctionAug 26, 2016Fitting Problem; Fitting Problem

  PROCEDURE PERFORMED: UNKNOWN - "DURING A PREPARATION FOR AN OPEN HEART SURGERY; TRIED TO ATTACH THE INSERT TO A CLAMP, THE INSERT WAS NOT ATTACHED CORRECTLY TO THE CLAMP. A CLINICAL NURSE CONFIRMED THAT A BURR WAS FOUND AT THE ATTACHMENT BUTTON OF THE FIBRA-SIDE INSERT. ANOTHER PACK OF INSERT FROM SAME LOT WAS USED FOR THE SURGERY. NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT. THEY EXPERIENCED THE SAME EVENT SEVERAL TIMES RECENTLY. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE." COMMENTS FROM SALES REPRESENTATIVE: "IT WAS CONFIRMED THAT THE ATTACHMENT BUTTON WAS SHAVED, BUT THE BURR COULDN'T CONFIRM. THE CLINICAL NURSE STATED THAT THERE WAS THE BURR ON THE ATTACHMENT BUTTON AT THE TIME OF SURGERY PREPARATION. IT MIGHT HAVE COME OFF. "

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5907196 ↗
• MalfunctionAug 16, 2016Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED: UNKNOWN . EVENT DESCRIPTION: (ON (B)(6) 2016). DURING A SURGERY, TRIED TO ATTACH AN INSERT TO A CLAMP TO BLOCK THE ASCENDING AORTA, THE INSERT FELL OFF FROM THE CLAMP. THE INSERT WAS REMOVED AND ANOTHER PACK OF INSERT WAS ATTACHED. HOWEVER, THE SECOND PAIR OF INSERT WAS NOT ATTACHED TO AND FELL OFF AGAIN. ANOTHER PACK OF INSERT WAS USED FOR THE THIRD TRY. THE THIRD PAIR OF INSERT WAS SUCCESSFULLY ATTACHED. THERE WAS NO BIG IMPACT TO THE SURGERY. NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT. THE HOSPITAL EXPERIENCED THE SAME EVENT BEFORE. THE CUSTOMER RECOGNIZED THAT THERE IS A QUALITY IRREGULARITY OF THE LOT-TO-LOT VARIATION OF THIS PRODUCT. COMMENTS FROM COSMOTEC; TWO (2) UNITS OF INSERT WERE RETURNED FROM THE CUSTOMER. WE CONFIRMED THE DEVICES AND FOUND THAT SOME OF THE ATTACHMENT BUTTONS WERE SHAVED. THE SAMPLES WILL BE RETURNED TO APPLIED MEDICAL. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE." TYPE OF INTERVENTION: "UNKNOWN." PATIENT STATUS: "NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5880762 ↗
• MalfunctionAug 16, 2016Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: (ON (B)(6) 2016) DURING A SURGERY, TRIED TO ATTACH AN INSERT TO A CLAMP TO BLOCK THE ASCENDING AORTA, THE INSERT FELL OFF FROM THE CLAMP. THE INSERT WAS REMOVED AND ANOTHER PACK OF INSERT WAS ATTACHED. HOWEVER, THE SECOND PAIR OF INSERT WAS NOT ATTACHED TO AND FELL OFF AGAIN. ANOTHER PACK OF INSERT WAS USED FOR THE THIRD TRY. THE THIRD PAIR OF INSERT WAS SUCCESSFULLY ATTACHED. THERE WAS NO BIG IMPACT TO THE SURGERY. NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT. THE HOSPITAL EXPERIENCED THE SAME EVENT BEFORE. THE CUSTOMER RECOGNIZED THAT THERE IS A QUALITY IRREGULARITY OF THE LOT-TO-LOT VARIATION OF THIS PRODUCT. COMMENTS FROM COSMOTEC; TWO (2) UNITS OF INSERT WERE RETURNED FROM THE CUSTOMER. WE CONFIRMED THE DEVICES AND FOUND THAT SOME OF THE ATTACHMENT BUTTONS WERE SHAVED. THE SAMPLES WILL BE RETURNED TO APPLIED MEDICAL. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE." TYPE OF INTERVENTION: "UNKNOWN." PATIENT STATUS: "NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5880745 ↗