Official recall record
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-09-17
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Zimmer, Inc.
What the authority reported
A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail piece. This allows the scope to move further into the plastic sheath that runs the length of the device, resulting in an interference fit at the cone, may caus an extension in surgery
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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