Skip to main content
CriticalFDAfda-Z-0007-2014OTHER

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

⚠ Critical Alert — Stop Using Immediately

This product has been flagged with severe risks (other). Stop using it now and contact the brand or FDA for a refund, repair, or replacement.

Units Affected
4,112
Recall Date
September 30, 2013
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0007-2014.

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.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0007-2014.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Bard Peripheral Vascular Inc or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0007-2014.

Bard Peripheral Vascular Inc

FDA

About the U.S. Food and Drug Administration

The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

Visit FDA.gov →

📣 Report a food, supplement, or cosmetic problem to the FDA

If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.

How to report to FDAFile a report at FDA

Bard Peripheral Vascular Inc Recall FAQ

Bard Peripheral Vascular Inc is the subject of a medical implants safety report: Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent Sy.... The notice was published on September 30, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 4,112 units are potentially affected.