Z-1740-2020 Class II Ongoing

Recalled by Boston Scientific — Marlborough, MA

Recall Details

Product Type
Devices
Report Date
April 29, 2020
Initiation Date
March 9, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19 units

Product Description

Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080

Reason for Recall

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

Distribution Pattern

Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

Code Information

Lot Numbers: 24749818, 24913418