SOFT / FIBRA® CLAMP INSERT G-6150Recalls & reported problems
Applied Medical Resources Corporation · SURGICAL CLAMP INSERTS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915111267), received between Mar 29, 2022 and Mar 29, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2022Break; Break
PROCEDURE PERFORMED: CORONARY ARTERY BYPASS GRAFTING EVENT DESCRIPTION: DURING A PREPARATION FOR PROCEDURE, IT WAS FOUND THE BASE PART OF INSERT WAS BROKEN BEFORE USE. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM BY USING ANOTHER G6150. THE INSERT IN QUESTION WILL BE RETURNED TO YOU FOR THE INVESTIGATION. PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: THE PROCEDURE WAS COMPLETED WITH NO PROBLEM BY USING ANOTHER G6150. PATIENT STATUS: NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13943618 ↗
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- TR BAND TRB24-REGTerumo Medical Corporation · CLAMP, VASCULAR284 reports
- TR BAND TRB24-REGTerumo Medical Corporation · CLAMP, VASCULAR256 reports
- HeartString III Proximal Seal HS-3045Maquet Cardiovascular LLC · Clamp, Vascular1 recall187 reports
- TR BAND TRB29-LRGTerumo Medical Corporation · CLAMP, VASCULAR67 reports
- TR BAND TRB29-LRGTerumo Medical Corporation · CLAMP, VASCULAR65 reports
- Flo-Thru Intraluminal Shunt® FT-12225Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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