Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss
Medtronic Vascular is recalling 7,839 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
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect that could expose sharp stainless-steel wires, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Medtronic Vascular is recalling 7,839 units of the Sherpa NX Active Guiding Catheter, 6F EBU4.0, .070" (Reference SA6EBU40), for cardiovascular use. The recall affects all lot and serial numbers, identified by GTIN 00613994823526.
The recall is being conducted because there is 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 next steps for this recall.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0, .070", REF SA6EBU40. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 7,839
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:00613994823526 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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