Z-1732-2020 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
225

Product Description

Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 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: 24538844, 24647121