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