Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling specific 6F Sherpa NX Active Guiding Catheters because a defect may cause loss of primary segment material, exposing 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 during use, representing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Vascular is recalling the SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0 SH, 100CM, 070", REF SA6SR40SH, intended for cardiovascular use. The recall is due to a potential defect where extensive loss of primary segment material may occur on a subset of these catheters, which could expose the underlying stainless-steel braid wires.
The affected devices 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 recall applies to all lot and serial numbers for the GTIN 00613994822765.
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, SR4.0 SH, 100CM, 070", REF SA6SR40SH. 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: 00613994822765 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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