SOFT / FIBRA® CLAMP INSERT G-3350Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915111243), received between Apr 7, 2017 and Nov 21, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PROCEDURE PERFORMED: CARDIAC SURGERY. EVENT DESCRIPTION: [HOSPITAL NAME], MODEL: G3350, LOT: 1548224. ON (B)(6) 2025: [PROCEDURE: CARDIAC SURGERY]. IT WAS IDENTIFIED THAT THE RUBBER PART OF THE INSERT DETACHED FROM THE PRODUCT DURING USE. THE SURGEON THEN CHECKED ANOTHER INSERT THAT HAD BEEN USED FOR THE BLOCKAGE AND FOUND THAT THE SAME ISSUE HAD OCCURRED WITH THAT INSERT AS WELL. THIS INDICATES THAT THE TOTAL QUANTITY OF AFFECTED PRODUCTS WAS TWO UNITS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REPLACING THEM WITH NEW ONES. PLEASE NOTE THAT BOTH DETACHMENTS WERE ONLY PARTIAL AND THE RUBBER PARTS DID NOT FALL INTO THE PATIENT¿S BODY. CONSEQUENTLY, THESE ISSUES DID NOT NEGATIVELY AFFECT THE PATIENT. THE PRODUCTS IN QUESTION WERE DISPOSED OF AT THE HOSPITAL. PATIENT STATUS: NO CLINICAL IMPACT. INTERVENTION: THESE DEVICES WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624848 ↗
• MalfunctionNov 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PROCEDURE PERFORMED: CARDIAC SURGERY. EVENT DESCRIPTION: [HOSPITAL NAME] MODEL G3350 LOT 1548224 ON (B)(6) 2025 [PROCEDURE: CARDIAC SURGERY]. IT WAS IDENTIFIED THAT THE RUBBER PART OF THE INSERT DETACHED FROM THE PRODUCT DURING USE. THE SURGEON THEN CHECKED ANOTHER INSERT THAT HAD BEEN USED FOR THE BLOCKAGE AND FOUND THAT THE SAME ISSUE HAD OCCURRED WITH THAT INSERT AS WELL. THIS INDICATES THAT THE TOTAL QUANTITY OF AFFECTED PRODUCTS WAS TWO UNITS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REPLACING THEM WITH NEW ONES. PLEASE NOTE THAT BOTH DETACHMENTS WERE ONLY PARTIAL AND THE RUBBER PARTS DID NOT FALL INTO THE PATIENT¿S BODY. CONSEQUENTLY, THESE ISSUES DID NOT NEGATIVELY AFFECT THE PATIENT. THE PRODUCTS IN QUESTION WERE DISPOSED OF AT THE HOSPITAL. PATIENT STATUS: NO CLINICAL IMPACT. INTERVENTION: THESE DEVICES WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623643 ↗
• MalfunctionApr 7, 2017Detachment Of Device Component; Detachment Of Device Component

  EVENT DESCRIPTION: (ON (B)(6) 2017: DURING PROCEDURE) A MEDICAL STAFF ATTACHED THE INSERT TO A CLAMP. THEN THE MEDICAL STAFF FOUND THAT THE INSERT WHITE RUBBER SEPARATED FROM THE PLASTIC BASE. ANOTHER INSERT WAS USED FOR THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH NO PROBLEM. 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 6474312 ↗