Device product
Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
Z-1731-2020
Product summary
- Event
- Event 85227
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,565
- Official record key
device-enforcement:Z-1731-2020
Official wording
Reason: An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Code information: Lot Numbers: 24501748, 24506585, 24507390, 24507747, 24517205, 24517209, 24517211, 24526341, 24576484, 24576569, 24577900, 24579133, 24580102, 24583255, 24585905, 24586401, 24616721, 24617337, 24618334, 24724936, 24732742, 24737184, 24739802, 24790717, 24805720, 24860825, 24868932
Distribution pattern: Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
Derived failure modes
-
Unknown
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device