The Recall Desk
HighFDA (Devices)·Z-1899-2021·Announced 2021-06-23

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.

What this means for you

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; VEN
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Vascular Stent
Hazard
  • deployment-failure
  • device-malfunction

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

Distributed nationwide across the United States.

Related recalls

Same category