# FDA recall Z-0718-2020

> **Bard Peripheral Vascular Inc** · Class II · device recall initiated 2019-02-18.

## Product

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

127 units were distributed in Australia to 32 Consignees.

## Key facts

- **Recall number:** Z-0718-2020
- **Recalling firm:** Bard Peripheral Vascular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-18
- **Report date:** 2019-12-25
- **Termination date:** 2021-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0718-2020

## Citation

> AI Analytics. FDA recall Z-0718-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0718-2020. Source: US FDA. Licensed CC0.

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