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 material loss, exposing 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 recall is classified as FDA Class I, which mandates a severity score of at least 4 according to the rubric, as it involves a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Medtronic Vascular is recalling the Sherpa NX Active Guiding Catheter, 6F, RCB, 90CM, 070", REF SA6RCBD, for cardiovascular use. The recall affects all lot and serial numbers for the GTIN 00613994822901. The product was 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.
The recall was initiated 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 source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Healthcare providers and consumers should stop using the affected catheters and contact Medtronic Vascular for further instructions or a replacement. The recall is classified as Class I by the FDA.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB, 90CM, 070", REF SA6RCBD. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 1
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: 00613994822901 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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