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Recall Observatory FDA recall evidence

Device product

Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only

Z-2268-2024

May 10, 2024

Class II

Product summary

Firm
Stryker Sustainability Solutions
Event
Event 94726
Status
Ongoing
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-2268-2024

Official wording

Reason: Diagnostic electrophysiology (EP) catheters do not meet testing requirements.

Code information: (UDI):00885825011680/Serial #: 4175411, 4202651, 4116975, 4202652, 4175410, 4175402

Distribution pattern: International distribution to the country of Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Diagnostic electrophysiology (EP) catheters do not meet testing requirements.