LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80...
FDA Device Recall #Z-0718-2020 — Class II — February 18, 2019
Recall Summary
| Recall Number | Z-0718-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 18, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bard Peripheral Vascular Inc |
| Location | Tempe, AZ |
| Product Type | Devices |
| 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.
Lot / 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
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|---|---|---|---|
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| Z-1244-2025 | Class I | Rotarex Atherectomy System and Instructions for... | Feb 5, 2025 |
| Z-0467-2025 | Class II | Bard Marquee Disposable Core Biopsy Instrument ... | Sep 30, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.