Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss
Medtronic Vascular is recalling 1,479 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. Additionally, the exposure of stainless-steel braid wires in a cardiovascular catheter represents a significant structural defect with potential for serious injury.
Plain-English summary
Medtronic Vascular is recalling 1,479 units of the Sherpa NX Active Guiding Catheter, 6F AL.75, .070" (Reference SA6AL75), for cardiovascular use. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-2641-2019.
The recall is due to a potential for extensive loss of primary segment material on a subset of the 6F Sherpa catheters. This defect could result in the exposure of underlying stainless-steel braid wires. The affected products were distributed worldwide to the United States, Austria, Belgium, Bulgaria, the Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, the Netherlands, Poland, Portugal, the Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and the United Kingdom.
The source text does not specify instructions for consumers or healthcare providers regarding the immediate handling of these devices. The recall covers all lot and serial numbers for the GTIN 00613994823977.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75, .070", REF SA6AL75. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 1,479
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: 00613994823977 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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