BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiolog...
FDA Device Recall #Z-0766-2019 — Class II — December 17, 2018
Recall Summary
| Recall Number | Z-0766-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 17, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Sustainability Solutions |
| Location | Tempe, AZ |
| Product Type | Devices |
| Quantity | 103 units |
Product Description
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
Reason for Recall
Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are used with CARTO(R) EP Navigation Systems.
Distribution Pattern
US distribution to states of: GA, KS, MO FL, CA, WA, IA,; and internationally to: Germany, Japan and Canada.
Lot / Code Information
Lot Codes: 2674940 2724318 2761521 2794036 2879309 2918829 2677298 2724320 2763683 2794073 2879312 2920167 2677324 2726887 2767521 2794191 2887266 2925629 2677325 2727015 2767528 2804281 2887691 2925630 2677326 2727016 2767537 2843017 2889131 2925632 2677327 2732728 2777174 2843547 2892701 2925633 2677328 2736609 2777175 2862775 2893277 2930750 2677331 2742516 2777185 2862776 2896226 2930753 2677398 2742579 2777186 2869100 2896229 2941324 2677399 2742580 2777187 2871151 2898832 2970121 2683282 2746664 2786407 2873812 2898836 2970300 2692529 2746673 2786426 2873898 2898840 2970301 2692536 2751680 2786502 2873899 2898845 2970302 2719705 2755589 2786506 2873924 2898846 2986705 2719707 2755641 2786537 2873935 2906003 2993057 2724210 2755694 2786538 2875420 2906077 3002383 2724283 2761520 2786568 2876114 2917968 3002384 3007144
Other Recalls from Stryker Sustainability Solutions
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2182-2026 | Class II | BARD EP XT Steerable, Product Number 200794; RE... | Apr 10, 2026 |
| Z-2191-2026 | Class II | Daig Livewire Steerable, Product Number 401904;... | Apr 10, 2026 |
| Z-2181-2026 | Class II | BARD EP XT Decapolar Steerable, Product Number ... | Apr 10, 2026 |
| Z-2187-2026 | Class II | Daig Livewire Steerable, Product Number 401581;... | Apr 10, 2026 |
| Z-2177-2026 | Class II | BARD Dynamic Tip Steerable, Product Number 6DYN... | Apr 10, 2026 |
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.