Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 39 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I. According to the severity rubric, an FDA Class I recall requires a score of 5 (Critical).
Plain-English summary
Medtronic Vascular is recalling 39 units of the Sherpa NX Active Guiding Catheter, 6F, JR4.0, 55cm, 070 inch, reference SA6JR40K. This medical device is intended for cardiovascular use. The recall affects all lot and serial numbers for the GTIN 00613994822291.
The recall is being conducted because there is a potential for extensive loss of primary segment material on a subset of these 6F Sherpa catheters. This defect may 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, 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. Healthcare providers should stop using the affected devices and contact Medtronic Vascular for instructions on return or replacement.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 55CM, 070", REF SA6JR40K. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 39
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: 00613994822291 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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