Device product

Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2190-2026

April 10, 2026

Class II

Product summary

Firm: Stryker Sustainability Solutions
Event: Event 98708
Status: Ongoing
Classification: Class II
Quantity: 24 units
Official record key: device-enforcement:Z-2190-2026

Official wording

Reason: Incomplete seals on sterile product

Code information: UDI 00885825006983, Lot Numbers: 3430230, 4648604, 4945422, 4999751, 5044134, 5059493, 4454505, 4882788, 4950218, 4999755, 5044135, 5086419, 4454517, 4945388, 4993562, 5044132, 5044136, 5086420, 4648603, 4945405, 4993565, 5044133, 5044137.

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