PROXIMATE TVR55Recalls & reported problems
Ethicon Endo-Surgery, LLC · PROXIMATE VASCULAR LINEAR CUTTER RELOAD, 55mm, White · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705036013396), received between Sep 29, 2023 and Mar 6, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert1
- Failure to Fire1
- Failure to Form Staple1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT DURING A ROBOT ASSISTED GASTRECTOMY, THE CARTRIDGE COULD NOT BE INSERTED WHEN TRIED TO INSERT THE CARTRIDGE AT THE 2ND FIRING. IT WAS USED ON DUODENUM. ANOTHER CARTRIDGE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21538226 ↗MalfunctionSep 29, 2023Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TVR RELOAD MISFIRED WHILE USING IT. THERE WAS NO DELAYED TO THE SURGERY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17843072 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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