Endoscopic Vessel Harvesting System Recalled for Assembly Defect
Zimmer recalls the Venapax XL endoscopic vessel harvesting system due to assembly defects that may cause endoscope interference during surgery. A Gen 5 tail piece was incorrectly assembled to Gen 4 devices, affecting 432 units nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a manufacturing assembly defect in a surgical system that presents risk of harm during medical procedures. No injuries or illnesses have been reported, placing this within the rubric criterion of risk-of-harm products without reported injury.
Plain-English summary
Zimmer, Inc. is recalling the Saphena Medical Venapax XL Endoscopic Vessel Harvesting System used in minimally invasive arterial bypass surgery. The recall affects 432 units distributed nationwide (Item Number VPX4000, Lot Numbers 43DD6738 and 43DD8092).
A manufacturing defect has been identified in which a Gen 5 tail piece was assembled to a Gen 4 finished device. This assembly error creates a 0.178-inch difference in the distance from the endoscope slot to the tail piece end, allowing the scope to advance further into the plastic sheath that runs along the device length.
As a result, the endoscope may experience an interference fit at the cone junction, potentially causing the scope to become stuck or create friction during surgical use. This defect may extend surgical procedure time or cause procedural complications.
Healthcare facilities with affected units should contact Zimmer, Inc. for instructions on device inspection, replacement, or return. For complete details, consult the FDA recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-0285-2025.
The recalled product
- 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)
- Manufacturer
- Zimmer, Inc.
- Affected units
- 432
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI: +M718VPX40001/$$326051543DD6738Q
- +M718VPX4001/$$326062143DD8092J Lot Numbers: 43DD6738
- 43DD8092
Distribution
Distributed nationwide across the United States.
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