LIFESTREAM 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.
- Company
- Bard Peripheral Vascular Inc
- Recall Initiated
- February 18, 2019
- Posted
- December 19, 2019
- Terminated
- April 28, 2021
- Recall Number
- Z-0718-2020
- Quantity
- 127 Units
- Firm Location
- Tempe, AZ
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.
Distribution
127 units were distributed in Australia to 32 Consignees.
Lot / Code Info
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
Root Cause
Nonconforming Material/Component
Action Taken
On 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.