Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0007-2014 — Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral

U.S. FDA — Device Enforcement · United States · 2013-09-30 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0007-2014
Date of alert: 2013-09-30
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Bard Peripheral Vascular Inc
Product category: device
Product type: Devices

Reported risk: Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have determined a higher incidence rate of partial stent deployment associated with their use.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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