Home › Bard Peripheral Vascular, Inc. › LifeStent® Solo Vascular Stent
LifeStent® Solo Vascular Stent
Bard Peripheral Vascular, Inc. · Model EX070401CL · UDI-DI 04049519004136
NIP
Prescription
0
510(k) clearances
10,573
Adverse events (185 deaths)
86
Recalls
39
Facilities
Description
LIFESTENT® SOLO™ Vascular Stent System 7 mm x 40 mm (80 cm delivery catheter)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-20 | Medtronic Inc. | Seal defects could compromise the ability of the product packaging to maintain sterility. |
| 2022-07-14 | Medtronic Inc. | Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment. |
| 2019-11-14 | Cardinal Health Inc. | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI |
| 2017-11-06 | Boston Scientific Corporation | Stent possibly unable to be fully released from the delivery system. |
| 2017-11-06 | Boston Scientific Corporation | Stent possibly unable to be fully released from the delivery system. |
| 2017-11-03 | Medtronic Inc. | Stent length on the label may not match the length of the stent itself. |
| 2016-08-04 | Terumo Medical Corp | During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape |
| 2016-05-23 | Ev3, Inc. | Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex" Self-expanding Peripheral Stent Sys |
| 2013-09-30 | Bard Peripheral Vascular Inc | 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 associate |
| 2013-04-23 | Cordis Corporation | Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.