Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to ob...
FDA Device Recall #Z-0467-2019 — Class II — August 23, 2018
Recall Summary
| Recall Number | Z-0467-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 23, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Sustainability Solutions |
| Location | Tempe, AZ |
| Product Type | Devices |
| Quantity | 2 |
Product Description
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
Reason for Recall
Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.
Distribution Pattern
US: KS OUS: None
Lot / Code Information
Item Number Serial Number D134903 2519054 D134903 2534027 Note: Item # D134909 is not approved for reprocessing by Stryker s Sustainability Solutions Division. Therefore, SSS does not create or possess D134909 labeling. SSS did not receive labeling from the manufacturer.
Other Recalls from Stryker Sustainability Solutions
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0490-2026 | Class II | HARMONIC FOCUS Shears + Adaptive Tissue Technol... | Sep 24, 2025 |
| 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.