Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss
Medtronic Vascular is recalling specific Sherpa NX Active Guiding Catheters due to a potential loss of material that could expose underlying stainless-steel 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 metal wires during use, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Medtronic Vascular is recalling the Sherpa NX Active Guiding Catheter, 6F SCR4.0 SH, .070" (REF SA6SCR40SH), which is used for cardiovascular procedures. The recall involves a subset of these 6F catheters where there is a potential for extensive loss of primary segment material. This defect could result in the exposure of underlying stainless-steel braid wires.
The affected devices were distributed worldwide to the United States and various international locations, including 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 recall covers all lot and serial numbers for the specific GTIN 00613994822574.
Healthcare providers and facilities should stop using the affected catheters and contact Medtronic Vascular for further instructions on the recall process.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0 SH, .070", REF SA6SCR40SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
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: 00613994822574 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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