Bard LifeStent Solo Vascular Stent
Medical device recall Z-0007-2014. Published in FDA’s Enforcement Report on Oct 16, 2013.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 16, 2013. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 4112 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
4112 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Code:EX062001CL Lot Numbers: ANVG3284, ANVH2474, ANVJ1379, ANVJ2590, ANVK3364, ANVL2910, ANVG3862, ANVH2475, ANVJ2089, ANVK3149, ANVK3707, ANVH0592, ANVH3715, ANVK3150, ANVL2902. Product Code: EX062003CL Lot Numbers: ANVG3285…
Every code shown here, 1,998 characters
Product Code:EX062001CL Lot Numbers: ANVG3284, ANVH2474, ANVJ1379, ANVJ2590, ANVK3364, ANVL2910, ANVG3862, ANVH2475, ANVJ2089, ANVK3149, ANVK3707, ANVH0592, ANVH3715, ANVK3150, ANVL2902. Product Code: EX062003CL Lot Numbers: 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 ANVH0328 ANVH3278 ANVJ2091 ANVL0812 ANWA0701 ANWB1632 ANVH0329 ANVH3279 ANVJ2337 ANVL0813 ANWA0820 ANWD3081 ANVH0593 ANVH3434 ANVJ2591 ANVL0814 ANWA0821 ANWE1362 ANVH0594 ANVH3435 ANVK0075 ANVL1027 ANWA0857 ANWE1365 ANVH0596 ANVH3451 ANVK0076 ANVL1028 ANWA0858 ANWE1366 ANVH0597 ANVH3452 ANVK0077 ANVL1029 ANWA0859 ANWE1368 ANVH0598 ANVH3453 ANVK0078 ANVL1219 ANWA0964 ANWE2371 ANVH0997 ANVH3454 ANVK0474 ANVL1220 ANWA0965 ANWE2864 ANVH0998 ANVH3716 ANVK0552 ANVL1221 ANWA0966 ANWE3415 ANVH0999 ANVH3717 ANVK0755 ANVL1391 ANWA0967 ANWE3416 ANVH1000 ANVH3718 ANVK0756 ANVL1392 ANWA1125 ANWE3550 ANVH1001 ANVI0132 ANVK0871 ANVL1393 ANWA1373 ANWE3551 ANVH1002 ANVI0134 ANVK0872 ANVL1394 ANWA1384 ANWE3552 ANVH1182 ANVI0135 ANVK1133 ANVL1604 ANWA1385 ANWE3685 ANVH1183 ANVI0136 ANVK1134 ANVL1605 ANWA1388 ANWE3686 ANVH1184 ANVI0311 ANVK1253 ANVL1608 ANWA1390 ANWE3982 ANVH1185 ANVI0808 ANVK1461 ANVL1609 ANWA1391 ANWE4134 ANVH1186 ANVI0967 ANVK1462 ANVL1762 ANWA1395 ANWE4135 ANVH1187 ANVI1251 ANVK1463 ANVL1763 ANWA1396 ANWE4136 ANVH1188 ANVI1252 ANVK1669 ANVL1764 ANWA1397 ANWF0178 ANVH1189 ANVI2510 ANVK1670 ANVL1765 ANWA1398 ANWF0179 ANVH1190 ANVI2511 ANVK1671 ANVL2346 ANWA1399 ANWF0180 ANVH1191 ANVI2513 ANVK1982 ANVL2347 ANWA1400…
FDA’s list runs to 4,253 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide Distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 30, 2013.
- FDA classified it on Oct 10, 2013.
- FDA’s Enforcement Report published it on Oct 16, 2013.
- FDA terminated it on Feb 5, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Bard Peripheral Vascular Inc, of Tempe, AZ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,253 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.