Fibra / Fibra® CLAMP INSERTS G-6155Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915111274), received between Nov 29, 2017 and Aug 7, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Unintended Ejection; Unintended Ejection

  PROCEDURE PERFORMED: CARDIAC SURGERY. EVENT DESCRIPTION: [DISTRIBUTOR NAME] [HOSPITAL NAME]: MODEL: G6155 LOT: 1422015. ON (B)(6) 2025 [PROCEDURE: CARDIAC SURGERY]. IT WAS REPORTED THAT THE INSERT IN QUESTION COULD NOT BE PROPERLY ATTACHED TO THE CLAMP. AT THE BEGINNING OF THE PROCEDURE, A NURSE SET UP THE INSERT TO A CLAMP, BUT IT APPEARED THAT THE INSERT COULD NOT BE PROPERLY SECURED. AS A RESULT, THE SURGEON NOTICED A LOSS OF OCCLUSION OR SENSED SOMETHING WAS WRONG DURING USE. AN ATTEMPT WAS MADE TO REATTACH THE INSERT TO THE CLAMP, BUT IT WAS UNSUCCESSFUL AND THE INSERT WAS REPLACED WITH A NEW ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE NEW INSERT. THE PRODUCT IN QUESTION WILL BE RETURNED TO YOU FOR THE INVESTIGATION. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE. THE HOSPITAL HAS REQUESTED THE INVESTIGATION REPORT. THERE WAS NO CLINICAL IMPACT TO THE PATIENT. PATIENT STATUS NO PATIENT INJURY INDICATED INTERVENTION: THE INSERT WAS REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE NEW INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745393 ↗
• MalfunctionNov 29, 2017Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED: "UNKNOWN" INCIDENT DESCRIPTION: A MEDICAL STAFF TRIED TO ATTACH THE INSERT TO A CLAMP. THEN THE MEDICAL STAFF FOUND THAT THE PART OF FIBRA WAS PEELED OFF FROM THE RUBBER BASE. ANOTHER INSERT WAS USED FOR THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH NO PROBLEM. IT DIDN'T AFFECT THE PATIENT." TYPE OF INTERVENTION: "ANOTHER INSERT WAS USED FOR THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH NO PROBLEM." PATIENT STATUS: "IT DIDN'T AFFECT THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7068013 ↗