GeniClip 350-000-103Recalls & reported problems
Genicon, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00877972004554), received between Jul 9, 2020 and Jul 9, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2020Material Split, Cut or Torn
DISTRIBUTOR HAS RECEIVED COMPLAINTS FROM THEIR CUSTOMERS THAT CLIPS, PART NUMBER 350-000-103 AND LOT NUMBER 026214, WHICH THEY PURCHASED IN (B)(6) (2018) AREN'T SAFE BECAUSE THEY TORN AND MAKE TRAUMAS IN ARTERIES AND BILE DUCTS. THEY CAUSED A LOT OF BLEEDINGS INSIDE THE BODY. CUSTOMER BELIEVES THE CLIP APPLIER IS EITHER PART NUMBER 350-010-002, LOT NUMBER 07161229 OR LOT NUMBER 07161230.
Patient problems: Laceration(s)
MAUDE report 10253583 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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