VENOVO 9F Venous Stent System incomplete deployment and delivery system retention
Bard Peripheral Vascular recalls VENOVO Venous Stent System 9F due to reports that the proximal end fails to expand immediately upon deployment and remains connected to the delivery system.
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: This is an FDA Class II device malfunction affecting an implantable stent system. The failure to expand and detachment of the proximal end creates risk of serious harm through inadequate vessel support and potential thrombosis. No hospitalizations or injuries are reported in the source text.
Plain-English summary
Bard Peripheral Vascular Inc is recalling the VENOVO Venous Stent System 9F across multiple configurations and stent diameters and lengths. The recall affects a total of 23,029 devices (16,582 in the U.S.; 6,447 outside the U.S.), distributed worldwide.
The recall was initiated due to reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system. This malfunction represents a failure of the device to function as intended, potentially compromising the intended treatment effect and vessel support.
Healthcare providers and patients who have received a VENOVO Venous Stent System device should consult with Bard Peripheral Vascular Inc and their healthcare provider regarding their specific device and any necessary clinical follow-up.
The recalled product
- Product
- VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL14060 /Venovo 9F 14/60/1200mm OUS; VENEL14080 /Venovo 9F 14/80/1200mm OUS; VENEL14100 /Venovo 9F 14/100/1200mm OUS; VENEL14120 /Venovo 9F 14/120/1200mm OUS…
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Vascular Stent
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 (20)
- Product Code/GTIN: VENEL14040 /00801741102295
- VENEL14060 /00801741102301
- VENEL14080 /00801741102318
- VENEL14100 /00801741102325
- VENEL14120 /00801741102332
- VENEL14140 /00801741102349
- VENEL14160 /00801741102356
- VENEM14040 /00801741102226
- VENEM14060 /00801741102233
- VENEM14080 /00801741102240
- VENEM14100 /00801741102257
- VENEM14120 /00801741102264
- VENEM14140 /00801741102271
- VENEM14160 /00801741102288
- VENUL14040 /00801741103483
- VENUL14060 /00801741103490
- VENUL14080 /00801741103506
- VENUL14100 /00801741103513
- VENUL14120 /00801741103520
- VENUL14140 /00801741103537
Distribution
Part of a larger recall action
This product is one of 3 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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