PlainRecalls
FDA Devices Moderate Class II Ongoing

Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. Item Number: VPX4000 (7273)

Reported: November 13, 2024 Initiated: September 17, 2024 #Z-0285-2025

Product Description

Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. Item Number: VPX4000 (7273)

Reason for Recall

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

Details

Recalling Firm
Zimmer, Inc.
Units Affected
432 units
Distribution
Nationwide
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. Item Number: VPX4000 (7273). Recalled by Zimmer, Inc.. Units affected: 432 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on November 13, 2024. Severity: Moderate. Recall number: Z-0285-2025.