Device product
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
Z-1730-2020
Product summary
- Event
- Event 85227
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,785
- Official record key
device-enforcement:Z-1730-2020
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: 24484631, 24494135, 24494288, 24533782, 24584655, 24617736, 24625474, 24665994, 24723912
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