Stryker Sustainability Solutions: Medical Device Recall in 2018 - (Recall #: Z-0917-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 2, 2018

Date Posted: March 14, 2018

Recall Number: Z-0917-2018

Event ID: 79087

Reason for Recall:

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

Status: Terminated

Product Quantity: 8 devices

Code Information:

Serial numbers 2468846, 2468849, 2509029, 2489074, 2491174, 2500529, 2465989, and 2500528

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.

Voluntary or Mandated:

Voluntary: Firm initiated