Medtronic Recalls Sherpa NX Active Guiding Catheters
Medtronic Vascular is recalling 12 units of the SHERPA NX Active Guiding Catheter due to a potential for extensive loss of primary segment material, which exposes underlying stainless-steel braid wires.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of at least 4. Additionally, the exposure of underlying stainless-steel braid wires in a cardiovascular device presents a risk of death or serious injury, fitting the criteria for a Critical (5) severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has announced a Class I recall of the SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A, manufactured by Medtronic Vascular. This product is intended for cardiovascular use.
The recall affects 12 units distributed worldwide to the United States and several other countries including 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 affected units are identified by GTIN 00613994823779 and all lot/serial numbers.
According to the recall notice, there is a potential for extensive loss of primary segment material on a subset of these 6F Sherpa catheters. This defect exposes the underlying stainless-steel braid wires.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 12
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: 00613994823779 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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