Reported Oct 16, 2013 · Terminated

Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo…

Bard Peripheral Vascular Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bard Peripheral Vascular Inc · 1625 W 3rd St Ste 109 · Tempe, AZ · 85281-2438

Is this the product you have?

  • Bard LifeStent Solo Vascular Stent
  • Item NumbersEX062001CL, 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
Lot codes and dates
  • Product CodeEX062001CL
  • Lot Numbers
    • ANVG3284
    • ANVH2474
    • ANVJ1379
    • ANVJ2590
    • ANVK3364
    • ANVL2910
    • ANVG3862
    • ANVH2475
    • ANVJ2089
    • ANVK3149
    • ANVK3707
    • ANVH0592
    • ANVH3715
    • ANVK3150
    • ANVL2902
  • Product CodeEX062003CL
  • Lot Numbers

    274 of 274 codes

    • ANVG3285
    • ANVH1962
    • ANVJ1385
    • ANVK3655
    • ANVL2915
    • ANWA1414
    • ANVG3286
    • ANVH2125
    • ANVJ1799
    • ANVL0001
    • ANWA0307
    • ANWA1415
    • ANVG3287
    • ANVH2126
    • ANVJ1800
    • ANVL0002
    • ANWA0308
    • ANWA1416
    • ANVG3882
    • ANVH2127
    • ANVJ1801
    • ANVL0169
    • ANWA0458
    • ANWA1419
    • ANVG3883
    • ANVH2185
    • ANVJ1802
    • ANVL0170
    • ANWA0459
    • ANWA3834
    • ANVG3884
    • ANVH2186
    • ANVJ1890
    • ANVL0364
    • ANWA0493
    • ANWA3855
    • ANVG3885
    • ANVH2187
    • ANVJ1891
    • ANVL0526
    • ANWA0494
    • ANWB0137
    • ANVH0325
    • ANVH2392
    • ANVJ1892
    • ANVL0527
    • ANWA0495
    • ANWB0139
    • ANVH0326
    • ANVH2393
    • ANVJ1893
    • ANVL0528
    • ANWA0698
    • ANWB1630
    • ANVH0327
    • ANVH3089
    • ANVJ2090
    • ANVL0811
    • ANWA0699
    • ANWB1631
  • Product CodeEX072001CL
  • Lot Numbers
    • ANVG3288
    • ANVI0969
    • ANVJ1134
    • ANVK3361
    • ANVL2913
    • ANVG3886
    • ANVI2302
    • ANVJ1135
    • ANVK3362
    • ANWA2569
    • ANVH0599
    • ANVJ0940
    • ANVJ2092
    • ANVL2903
    • ANWA2647
  • Product CodeEX072003CL
  • Lot Numbers

    150 of 150 codes

    • ANVG3289
    • ANVH2680
    • ANVJ0768
    • ANVK2434
    • ANVL2349
    • ANWA0707
    • ANVG3290
    • ANVH2833
    • ANVJ1133
    • ANVK2727
    • ANVL2350
    • ANWA0860
    • ANVG3887
    • ANVH2834
    • ANVJ2093
    • ANVK2728
    • ANVL2787
    • ANWA0861
    • ANVG3888
    • ANVH2835
    • ANVJ2338
    • ANVK3656
    • ANVL2788
    • ANWA0968
    • ANVG3889
    • ANVH3090
    • ANVJ2339
    • ANVK3657
    • ANVL2900
    • ANWA0969
    • ANVH0596
    • ANVH3091
    • ANVJ2593
    • ANVL0003
    • ANVL2905
    • ANWA1126
    • ANVH0597
    • ANVH3092
    • ANVJ2595
    • ANVL0004
    • ANVL2909
    • ANWA1386
    • ANVH0598
    • ANVH3280
    • ANVJ2596
    • ANVL0075
    • ANVL2911
    • ANWA1387
    • ANVH0600
    • ANVH3281
    • ANVK0473
    • ANVL0076
    • ANVL2916
    • ANWA2895
    • ANVH0601
    • ANVH3449
    • ANVK0757
    • ANVL0077
    • ANVL2917
    • ANWB0138
Amount recalled
4112 units

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 5, 2014 · Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.