Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Cathete...
FDA Device Recall #Z-0917-2018 — Class II — January 2, 2018
Recall Summary
| Recall Number | Z-0917-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 2, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Sustainability Solutions |
| Location | Tempe, AZ |
| Product Type | Devices |
| Quantity | 8 devices |
Product Description
Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. They are designed to obtain electrograms in the atrial regions of the heart. The Reprocessed 2515 NAV eco Variable EP Catheters provide location information when used with compatible CARTO EP Navigation Systems version 2.3 or higher.
Reason for Recall
An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
Distribution Pattern
USA (nationwide) Distribution was made to medical facilities in AZ, CA, CT, FL, GA, IL, KS, LA, MN, MO, OH, PA, TX, VT, WA, and Wi. Foreign distribution was made to Canada.
Lot / Code Information
Serial numbers 2468846, 2468849, 2509029, 2489074, 2491174, 2500529, 2465989, and 2500528
Other Recalls from Stryker Sustainability Solutions
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| Z-2689-2024 | Class II | Disposable 5 Lead Cable and Lead Wire System, 5... | Jul 2, 2024 |
| Z-2405-2024 | Class II | REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (... | May 31, 2024 |
| Z-2268-2024 | Class II | Stryker Sustainability Solutions, BW Lasso 2515... | May 10, 2024 |
| Z-2394-2023 | Class II | HoverMatt, 39" W x 78" L, REF: HM39SPU-B | Jun 21, 2023 |
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.