GEM COUPLER Forceps GEM4183CRecalls & reported problems
Synovis Micro Companies Alliance, Inc · Reusable instrument used to grasp the blood vessel and evert onto the GEM COUPLER rings. · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844735002850), received between Mar 5, 2025 and Feb 23, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Nov 2, 2018Open, Classified
Potential presence of rust on Coupler Forceps (GEM4183C).
Z-0680-2019 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Material Twisted/Bent3
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2026Material Twisted/Bent
IT WAS REPORTED THAT TWO (2) COUPLER FORCEPS HAD BENT TIPS. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24416710 ↗MalfunctionNov 29, 2025Material Twisted/Bent; Material Twisted/Bent
DURING EVALUATION OF A RETURNED COUPLER FORCEPS OBSERVED A MISALIGNMENT WHEN THE TIPS WERE CLOSED TOGETHER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675630 ↗MalfunctionNov 18, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE TIPS OF A COUPLER FORCEPS ARE DAMAGED/BENT. THIS WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23578158 ↗MalfunctionMar 5, 2025Defective Component; Defective Component
IT WAS REPORTED THAT THE TIPS OF A COUPLER FORCEPS WERE SIGNIFICANTLY MISALIGNED WHEN INSPECTED BEFORE BEING USED IN THE HOSPITAL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21531786 ↗
Other FORCEPS devices
- NA 314.291Synthes GmbH · FORCEPS177 reports
- NA 399.99Synthes GmbH · FORCEPS111 reports
- NA PDL114Synthes GmbH · FORCEPS81 reports
- AESCULAP BJ025RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP BJ058RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP BJ062RAesculap AG · FORCEPS1 recall0 reports
- ATRAUMATA FB440RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP BH813RAesculap AG · FORCEPS1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.