PlainRecalls
FDA Devices Critical Class I Terminated

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.

Reported: October 16, 2013 Initiated: September 30, 2013 #Z-0007-2014

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.

Details

Units Affected
4112 units
Distribution
US Nationwide Distribution.
Location
Tempe, AZ

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.

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