Medtronic Vascular: Medical Device Recall in 2019 - (Recall #: Z-2568-2019)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2019.
Data Source: FDA.
Product Description:
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL.75 110CM.070", REF SA6AL75A. for cardiovascular use
Product Classification:
Class I
Date Initiated: March 15, 2019
Date Posted: October 9, 2019
Recall Number: Z-2568-2019
Event ID: 82525
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.
Status: Completed
Product Quantity: 12 units
Code Information:
GTIN: 00613994823960 All Lot/Serial Numbers
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
Voluntary or Mandated:
Voluntary: Firm initiated