Bard Peripheral Vascular Inc: Medical Device Recall in 2019 - (Recall #: Z-0718-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 18, 2019

Date Posted: December 25, 2019

Recall Number: Z-0718-2020

Event ID: 84173

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.

Status: Terminated

Product Quantity: 127 Units

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

Distribution Pattern:

127 units were distributed in Australia to 32 Consignees.

Voluntary or Mandated:

Voluntary: Firm initiated