Z-0916-2018Class II

Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref...

Name: Z-0916-2018 Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref...
Creator: Stryker Sustainability Solutions
Published: 2018-01-02
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2018-01-02 / Terminated / root cause: design

FDA source

Stryker Sustainability Solutions began a recall of Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reprocessed 2515 NAV eco... on 2018-01-02. FDA classified it as Class II and gives the reason as "An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0916-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-02
Posted: 2018-03-06
Terminated: 2018-05-02
Recalling firm: Stryker Sustainability Solutions
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.
Product code: NLH Catheter, Recording, Electrode, Reprocessed
Reason for recall: An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker sent an Urgent Medical Device Recall letter dated January 2, 2018, explains the reason for recall, risk to health, and instructs them to discontinue use of the affected products. The customer is to check their inventory for the affected serial numbers provided in the attachment and complete the recall effectiveness check form to indicate the amount of product in inventory. Return instructions are provided. For further questions, please call (888) 763-8803.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0916-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0916-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-06
Z-0917-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-06

Product code NLH

K112292Class IIReprocessed 2515 Nav Variable Electrophysiology CatheterStryker Sustainability Solutions / cleared 2011-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)