Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 27 units of the Sherpa NX Active Guiding Catheter because the primary segment material may break, exposing 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 FDA classified this as a Class I recall, which indicates a reasonable probability that the product would cause serious adverse health consequences or death. The rubric states that FDA Class I recalls must be scored at least 4 (Severe). Although the source text does not explicitly mention reported injuries, the Class I designation mandates a minimum severity of Severe.
Plain-English summary
Medtronic Vascular is recalling a subset of 6F Sherpa NX Active Guiding Catheters (REF SA6SAL10SH) for cardiovascular use. The recall affects 27 units distributed worldwide to the US, 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. All lot and serial numbers are included.
The reason for the recall is a potential for extensive loss of primary segment material on these catheters. This defect exposes the underlying stainless-steel braid wires.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0 SH, .070", REF SA6SAL10SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 27
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: 00613994823182 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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