Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 163 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
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class I. According to the rubric, if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
Medtronic Vascular is recalling 163 units of the Sherpa NX Active Guiding Catheter, 6F ALR1-2, .070" (Reference SA6ALR12). The product is intended for cardiovascular use. The recall involves all lot and serial numbers for the GTIN 00613994823946.
The recall was initiated because there is a potential for extensive loss of primary segment material on a subset of the 6F Sherpa catheters. This defect could expose the underlying stainless-steel braid wires. The agency has classified this recall as Class I.
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. Healthcare providers and facilities should stop using the affected devices and contact Medtronic Vascular for further instructions.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2, .070", REF SA6ALR12. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 163
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: 00613994823946 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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