Z-1730-2020 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
1,785

Product Description

Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 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: 24484631, 24494135, 24494288, 24533782, 24584655, 24617736, 24625474, 24665994, 24723912