Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access fo
Summary
The FDA issued a Class II for Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minim by Zimmer, Inc.. Reason: 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 .
Details
Source
Device Recall
External ID
Z-0285-2025
Action Date
2024-11-13
Status
Ongoing
Category
device
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)
Lot/Code Info: UDI: +M718VPX40001/$$326051543DD6738Q, +M718VPX4001/$$326062143DD8092J Lot Numbers: 43DD6738, 43DD8092
Quantity Affected: 432 units
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
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-17
Company
Warsaw, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Zimmer, Inc. has 87 FDA actions in our database, including 65 recalls and 22 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zimmer, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zimmer, Inc. have FDA actions?
Zimmer, Inc. has 87 FDA actions in our database, including 65 recalls and 22 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0285-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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