Recall Z-0007-2014— Bard Peripheral Vascular Inc
Class I · Terminated
Class I FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2013-09-30, terminated 2014-02-05. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Bard Peripheral Vascular Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-09-30
- Terminated
- 2014-02-05
- Firm location
- Tempe, AZ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.