Device product
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.
Z-0916-2018
Product summary
- Event
- Event 79087
- Status
- Terminated
- Classification
- Class II
- Quantity
- 170 devices
- Official record key
device-enforcement:Z-0916-2018
Official wording
Reason: An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
Code information: 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.
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.
Derived failure modes
-
Unknown
An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.