Z-1731-2020 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
5,565

Product Description

Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit

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: 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