FDA Medical devices recall ·
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in… recall
- Recall number
- Z-0285-2025
- Date
- (initiated September 17, 2024)
- Company / brand
- Zimmer, Inc.
1800 W Center St, Warsaw, IN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 432 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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)
Why was it 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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: +M718VPX40001/$$326051543DD6738Q, +M718VPX4001/$$326062143DD8092J Lot Numbers: 43DD6738, 43DD8092
Distribution
Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0285-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.