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.
FDA Recall Z-0916-2018 · Posted None
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Recalling FirmStryker Sustainability Solutions
Recall StatusTerminated
Product CodeNLH
Date Initiated2018-01-02
Date Terminated2018-05-02
Product Quantity170 devices
Reason for Recall
An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
Firm 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.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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