Stryker Reprocessed Catheters Recall: EEPROM Error with CARTO EP Navigation Systems
Stryker recalls reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters due to potential EEPROM chip errors when used with CARTO EP Navigation Systems version 2.3 or higher.
Use caution until it’s fixed
An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
Contact the company
What happened, in plain English
Stryker is recalling reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters that may have EEPROM chip errors when used with CARTO EP Navigation Systems. This could lead to incorrect cardiac mapping during procedures, potentially affecting patient safety. Read more at govinfonow.com/recall/72196-stryker-reprocessed-catheters-recall-eeprom-error-with-carto-ep-navigation.
Source Summary by GovInfoNow · govinfonow.com/recall/72196-stryker-reprocessed-catheters-recall-eeprom-error-with-carto-ep-navigation · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0916-2018
Cite this page
“Stryker Reprocessed Catheters Recall: EEPROM Error with CARTO EP Navigation Systems.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72196-stryker-reprocessed-catheters-recall-eeprom-error-with-carto-ep-navigation. Based on FDA recall #Z-0916-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0916-2018%22&limit=1).
Why it’s dangerous
The catheters may display incorrect error codes when used with CARTO EP Navigation Systems version 2.3 or higher, which could lead to improper cardiac mapping during electrophysiology procedures. This might result in ineffective treatment or unintended complications.
Who’s affected
Healthcare providers using these catheters for cardiac electrophysiology procedures are most at risk. Patients undergoing such procedures with the recalled catheters could experience inaccurate mapping results.
How to tell if you have this one
Check for the serial numbers listed in the recall notice (e.g., 2451387, 2484264, etc.). The catheters are reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters with reference number D134301.
- Brand
Stryker Sustainability Solutions- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0916-2018 | Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, 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.; Serial numbers 2451387, 2484264, 2484471, 2486823, 2487380, 2488350, 2490592, 2490605, 2492930, 2494064, 2494067, 2495242, 2495335, 2495337, 2495339, 2500403, 2500911, 2510524, 2518512, 2523848, 2523849, 2523851, 2525678, 2528071, 2534854, 2534856, 2608429, 2609031, 2609102, 2609105, 2609106, 2609107, 2609985, 2610794, 2610802, 2614613, 2614847, 2614909, 2615094, 2615098, 2615099, 2615319, 2615646, 2615712, 2615722, 2615725, 2615937, 2615938, 2615940, 2615943, 2615952, 2615966, 2616087, 2616088, 2616089, 2616090, 2616212, 2617794, 2617920, 2617987, 2617999, 2618010, 2618258, 2618832, 2618837, 2618881, 2618884, 2618990, 2618992, 2618993, 2619615, 2619742, 2619744, 2619827, 2620937, 2620942, 2620945, 2621283, 2621384, 2621385, 2621387, 2621424, 2621425, 2621847, 2621860, 2621880, 2623972, 2623974, 2624006, 2624010, 2624113, 2624138, 2625427, 2625536, 2625550, 2625623, 2625625, 2626330, 2626348, 2626929, 2626966, 2626988, 2627596, 2627946, 2627948, 2627949, 2629162, 2629164, 2630084, 2630085, 2630087, 2630351, 2631186, 2631188, 2631189, 2631191, 2631680, 2632641, 2633968, 2634008, 2634252, 2634271, 2634596, 2634709, 2634815, 2634836, 2635075, 2635077, 2635342, 2635343, 2635867, 2635873, 2636658, 2636759, 2636906, 2636986, 2637009, 2637022, 2637023, 2637233, 2637234, 2637237, 2637239, 2637257, 2637308, 2637495, 2637497, 2640103, 2640106, 2640107, 2640118, 2640119, 2642853, 2643222, 2643426, 2643432, 2646002, 2647122, 2669947, 2693960, 2696255, 2705129, 2708915, 2708916, 2712736, 2712756, 2713556, 2713593, 2713595, and 2713596. | 170 devices |
| Z-0917-2018 | 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.; Serial numbers 2468846, 2468849, 2509029, 2489074, 2491174, 2500529, 2465989, and 2500528 | 8 devices |
What to do — step by step
Check Serial Numbers
Verify if your catheters have any of the listed serial numbers (e.g., 2451387, 2484264, etc.).
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 16 states.
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Minnesota, Missouri, Ohio, Pennsylvania, Texas, Vermont, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 4 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0916-2018 (January 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0916-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.