Device product

Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2188-2026

April 10, 2026

Class II

Product summary

Firm: Stryker Sustainability Solutions
Event: Event 98708
Status: Ongoing
Classification: Class II
Quantity: 19 units
Official record key: device-enforcement:Z-2188-2026

Official wording

Reason: Incomplete seals on sterile product

Code information: UDI 00885825006884, Lot Numbers: 3002664, 4092049, 4580888, 4627994, 4778840, 4860529, 4998452, 4026540, 4098358, 4620256, 4627999, 4813542, 4985859, 4072508, 4498128, 4620257, 4755333, 4860528, 4985861.

Distribution pattern: US Nationwide and the countries of Israel and Canada.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Incomplete seals on sterile product