Medtronic Recalls Six Sherpa NX Active Guiding Catheters for Material Loss
Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the agency classification as Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter, 6F, MB1, 90CM, 070", REF SA6MB1D. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-2596-2019.
The recall is due to a potential for extensive loss of primary segment material on a subset of these 6F Sherpa catheters. This defect could expose the underlying stainless-steel braid wires. The agency has classified this recall as Class I.
The affected units were distributed worldwide to the United States, 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 the United Kingdom. The GTIN for the product is 00613994821959, and the recall applies to all lot and serial numbers.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, MB1, 90CM, 070", REF SA6MB1D. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 00613994821959 All Lot/Serial Numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 191 recalled by Medtronic Vascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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