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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81880

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 17, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Sustainability Solutions

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0766-2019
Recall number
Z-0766-2019
Initiated
December 17, 2018
Classification
Class II
Status
Terminated
Quantity
103 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

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Inspect official wording and provenance

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.

Code information

Lot Codes: 2674940 2724318 2761521 2794036 2879309 2918829 2677298 2724320 2763683 2794073 2879312 2920167 2677324 2726887 2767521 2794191 2887266 2925629 2677325 2727015 2767528 2804281 2887691 2925630 2677326 2727016 2767537 2843017 2889131 2925632 2677327 2732728 2777174 2843547 2892701 2925633 2677328 2736609 2777175 2862775 2893277 2930750 2677331 2742516 2777185 2862776 2896226 2930753 2677398 2742579 2777186 2869100 2896229 2941324 2677399 2742580 2777187 2871151 2898832 2970121 2683282 2746664 2786407 2873812 2898836 2970300 2692529 2746673 2786426 2873898 2898840 2970301 2692536 2751680 2786502 2873899 2898845 2970302 2719705 2755589 2786506 2873924 2898846 2986705 2719707 2755641 2786537 2873935 2906003 2993057 2724210 2755694 2786538 2875420 2906077 3002383 2724283 2761520 2786568 2876114 2917968 3002384 3007144

Distribution pattern

US distribution to states of: GA, KS, MO FL, CA, WA, IA,; and internationally to: Germany, Japan and Canada.