Device product
Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
Z-1740-2020
Product summary
- Event
- Event 85227
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 19 units
- Official record key
device-enforcement:Z-1740-2020
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: 24749818, 24913418
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