Agency classClass IIOur severity:High FDA (Devices)·Z-1897-2021·Announced 2021-06-23

VENOVO Venous Stent System Recalled for Deployment Malfunction

The FDA is recalling VENOVO Venous Stent System units due to reports that the proximal end may fail to expand immediately upon deployment and remain connected to the delivery catheter.

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 classification combined with a device malfunction (improper stent expansion and deployment failure) creates risk-of-harm. No illnesses or injuries are reported in the source text, placing this in the High category rather than Severe.

Plain-English summary

VENOVO Venous Stent System is recalled due to reports of the proximal end not immediately expanding upon deployment and remaining connected to the delivery system. The affected units were distributed worldwide, with 46,878 devices distributed in the United States and 10,637 devices distributed outside the United States.

Healthcare providers and facilities should verify whether they have received affected devices by checking the product codes and serial numbers listed in the FDA recall notice. Patients who may have received this device should consult with their healthcare provider regarding whether they are affected.

The recalled product

Product: VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS VENEL16060 Venovo 10F 16/60/1200mm OUS VENEL16080 Venovo 10F 16/80/1200mm OUS VENEL16100 Venovo 10F 16/100/1200mm OUS VENEL16120 Venovo 10F 16/120/1200mm OUS…
Manufacturer: Bard Peripheral Vascular Inc
Category: Medical Device — Vascular Stent
Hazard: deployment-failure
stent-expansion-failure

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: VENEL16040 /00801741102431
VENEL16060 /00801741102448
VENEL16080 /00801741102455
VENEL16100 /00801741102462
VENEL16120 /00801741102479
VENEL16140 /00801741102486
VENEL16160 /00801741102493
VENEL18040 /00801741102578
VENEL18060 /00801741102585
VENEL18080 /00801741102592
VENEL18100 /00801741102608
VENEL18120 /00801741102967
VENEL18140 /00801741102974
VENEL18160 /00801741102981
VENEL20040 /00801741103063
VENEL20060 /00801741103070
VENEL20080 /00801741103087
VENEL20100 /00801741103094
VENEL20120 /00801741103100
VENEL20140 /00801741103117

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 3 products in this recall →

Same manufacturer · Bard Peripheral Vascular Inc

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Same hazard · deployment failure