Z-2745-2019 Class I
FDA device recall Z-2745-2019 was initiated by Medtronic Vascular on March 15, 2019 and is designated Class I. 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. Affected quantity: 30 units.
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
- 30 units
Product Description
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL205. 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: 20613994842248 All Lot/Serial Numbers