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U.S. Department of Health and Human Services

Class 2 Device Recall LIFESTREAM Balloon Expandable Vascular Covered Stent

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 Class 2 Device Recall LIFESTREAM Balloon Expandable Vascular Covered Stentsee related information
Date Initiated by FirmFebruary 18, 2019
Date PostedDecember 19, 2019
Recall Status1 Terminated 3 on April 28, 2021
Recall NumberZ-0718-2020
Recall Event ID 84173
PMA NumberP160024 
Product Classification Iliac covered stent, arterial - Product Code PRL
ProductLIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 atm (1216 kPa) RX Only Lot numbers begins with CMA or CMB. Product Code Stent Diameter Stent length Catheter Length LSM0800626 6mm 26 mm 80 cm LSM1350626 6 mm 26 mm 135 cm LSM0800637 6 mm 37 mm 80 cm LSM1350637 6 mm 37 mm 135 cm LSM0800726 7 mm 26 mm 80 cm LSM1350726 7 mm 26 mm 135 cm Product Usage: The LIFESTREAM Balloon Expandable Vascular Covered Stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries with reference vessel diameters between 4.5 mm and 12.0 mm, and lesions lengths up to 100mm.
Code Information Begins with Lot Number CMA or CMB Product Code LSM0800626  Product Code LSM1350626  Product Code LSM0800637  Product Code LSM1350637  Product Code LSM0800726  Product Code LSM1350726
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
For Additional Information Contact
02-88754000
Manufacturer Reason
for Recall		Certain product code/lot number combinations may experience introducer sheath compatibility issues when used with a 6F introducer sheath. Using the affected balloon expandable vascular covered stents with a 6F introducer sheath could result in difficulty or the inability to insert or advance the catheter through the introducer sheath. This could potentially lead to a slight prolongation of the procedure.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 02/18/19, Urgent Product Defect Correction Notices were mailed to customers informing them to upsize to a 7F introducer sheath and to add relabeling stickers over the 6F introducer sheath size indication on the label. In addition, customers were asked to complete and return the Response Form. In addition, if the affected product has been further distributed, immediate action was requested to contact that location, advise them of the field correction notice and to forward the Urgent Product Defect Correction Notice to the affected customer. Customers having additional questions are encouraged to call 1-800-257-232.
Quantity in Commerce127 Units
Distribution127 units were distributed in Australia to 32 Consignees.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = PRL
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