Integra® CEV625T1URecalls & reported problems
Integra Microfrance · Integra® Johann fenestrated insert jaws with 20 mm tips, for 5 mm diameter tube, 310 mm length · Class 2
Data updated Oct 16, 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 10381780428664), received between May 7, 2025 and May 7, 2025 — 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 16, 2026.
Reports received per month
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.
MalfunctionMay 7, 2025Break; Break
THIS COMPLAINT IS 2 OF 2 FOR THE INSERT COMPONENT REPORTEDLY USED DURING THIS EVENT AND IS RELATED TO MFG NUMBER 3003249645-2025-00018: IT WAS REPORTED THAT "DURING AN OPERATION, THE SURGEON NOTICED A LOSS OF GRIP, MAKING IT IMPOSSIBLE TO RESUME GRIPPING DUE TO THE ABSENCE OF ONE OF THE FENESTRATED PADDLES". IT WAS SUBSEQUENTLY REPORTED THAT THE FRAGMENT OF THE JOHANN FENESTRATED INSERT (CEV625T1U) FELL INTO THE PATIENT'S ABDOMEN. IT WAS CONFIRMED THAT ALL PIECES WERE RETRIEVED WITHOUT ANY CONSEQUENCES TO THE PATIENT.; NO X-RAY WAS REQUIRED. IT WAS REPORTED THAT ANOTHER FORCEPS WAS USED TO FINALIZE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21976102 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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