STEALTH® FIBRA® CLAMP INSERT A0G04Recalls & reported problems
Applied Medical Resources Corporation · CLAMP INSERT · 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 00607915114756), received between Apr 7, 2017 and Apr 7, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
WE FINISHED OUR RECEIVING INSPECTION FOR INVOICE #(B)(4). SOME OF THE PRODUCTS DID NOT PASS THE RECEIVING INSPECTION BECAUSE OF PARTICULATE MATTER AND SO ON. WE WOULD LIKE APPLIED MEDICAL TO ISSUE CREDIT MEMO FOR THE REJECTED ITEMS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6474308 ↗
Other Clamp, Vascular devices
- Heartstring III System 3.8MM HSK-3038Maquet Cardiovascular LLC · Clamp, Vascular1 recall4 deaths809 reports
- Heartstring III System 4.3MM HSK-3043Maquet Cardiovascular LLC · Clamp, Vascular1 recall265 reports
- 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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