Z-2606-2019 Class I

Recalled by Medtronic Vascular — Danvers, MA

Recall Details

Product Type
Devices
Report Date
October 9, 2019
Initiation Date
March 15, 2019
Termination Date
April 26, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
49 units

Product Description

SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDC, 55CM, 070", REF SA6RDCK. for cardiovascular use

Reason for Recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Distribution Pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

Code Information

GTIN: 00613994823250 All Lot/Serial Numbers