Data Foundry

Medical device recalls 2013

Bard LifeStent Solo Vascular Stent — Class I medical device recall Z-0007-2014

Terminated recall by Bard Peripheral Vascular Inc, reported 2013-10-16, distributed nationwide. Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have de

Recall numberZ-0007-2014
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBard Peripheral Vascular Inc, Tempe, AZ, United States
Recall initiated2013-09-30
Classified2013-10-10
Reported by FDA2013-10-16
Terminated2014-02-05
DistributedNationwide (US)
Quantity4,112 units
Lot numbersANVG3284, ANVG3285, ANVG3286, ANVG3287, ANVG3288, ANVG3289, ANVG3290, ANVG3862, ANVG3882, ANVG3883, ANVG3884, ANVG3885, ANVG3886, ANVG3887, ANVG3888, ANVG3889, ANVH0325, ANVH0326, ANVH0327, ANVH0328, ANVH0329, ANVH0592, ANVH0593, ANVH0594, ANVH0596, ANVH0597, ANVH0598, ANVH0599, ANVH0600, ANVH0601, ANVH0602, ANVH0997, ANVH0998, ANVH0999, ANVH1000, ANVH1001, ANVH1002, ANVH1182, ANVH1183, ANVH1184 and 404 more
Model numbersEX062001CL, EX062003CL, EX072001CL, EX072003CL

Product

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 artery (SFA) and in the proximal popliteal artery with reference vessel diameters ranging from 4.0  6.5 mm.

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0007-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.