FDA Medical Device · 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.

Class II · Terminated

An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.

Affected lots / codes — check yours against thisSerial 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.

Recalling firm: Stryker Sustainability Solutions, Tempe, AZ
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 170 devices
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 initiated: January 2, 2018
Classified: March 6, 2018
Terminated: May 2, 2018
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0916-2018%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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