Z-0718-2020 Class II Terminated
FDA device recall Z-0718-2020 was initiated by Bard Peripheral Vascular Inc on February 18, 2019 and is designated Class II. 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… The recall status is terminated (terminated April 28, 2021). Affected quantity: 127 Units.
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2019
- Initiation Date
- February 18, 2019
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 127 Units
Product Description
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.
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 Pattern
127 units were distributed in Australia to 32 Consignees.
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