Data Foundry

Medical device recalls 2019

BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter — Class II medical device recall Z-0766-2019

Terminated recall by Stryker Sustainability Solutions, reported 2019-01-30, distributed in CA, FL, GA, IA, KS, MO, WA. Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPRO

Recall numberZ-0766-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmStryker Sustainability Solutions, Tempe, AZ, United States
Recall initiated2018-12-17
Classified2019-01-23
Reported by FDA2019-01-30
Terminated2023-12-08
DistributedCA, FL, GA, IA, KS, MO, WA
Countries outside the USCA, DE, JP
Quantity103 units
Lot numbers2674940, 2677298, 2677324, 2677325, 2677326, 2677327, 2677328, 2677331, 2677398, 2677399, 2683282, 2692529, 2692536, 2719705, 2719707, 2724210, 2724283, 2724318, 2724320, 2726887, 2727015, 2727016, 2732728, 2736609, 2742516, 2742579, 2742580, 2746664, 2746673, 2751680, 2755589, 2755641, 2755694, 2761520, 2761521, 2763683, 2767521, 2767528, 2767537, 2777174 and 63 more
Model numbersD134301

Product

BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.

Reason for recall

Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are used with CARTO(R) EP Navigation Systems.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0766-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.