Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported October 16, 2013
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.
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 associat…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bard Peripheral Vascular Inc recalled Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX0… - a critical-severity action.
Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX0… was recalled by Bard Peripheral Vascular Inc in October 16, 2013. Reason: Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have d…. Check the official notice for the remedy. Verify recall #Z-0007-2014 with the FDA Devices before acting.
The recall
Bard Peripheral Vascular Inc issued this critical-severity FDA Devices recall-Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have d….
- Critical
- severity level
- 4K units
- affected scope
- Class I
- classification
- October 16, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0007-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0007-2014) was formally reported on October 16, 2013, with the manufacturer initiating the action on September 30, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Bard Peripheral Vascular Inc is listed as the recalling firm, operating out of Tempe, AZ. Federal records list the affected scope as 4112 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Nationwide Distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4112 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0007-2014 |
| Date reported | October 16, 2013 |
| Date initiated | September 30, 2013 |
| Recalling firm | Bard Peripheral Vascular Inc |
| Firm location | Tempe, AZ |
| Affected scope | 4112 units |
| Distribution | US Nationwide Distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0007-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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.. Recalled by Bard Peripheral Vascular Inc. Units affected: 4112 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2013. Severity: Critical. Recall number: Z-0007-2014.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0007-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 16, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.