Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 12 units of the SHERPA NX ACTIVE GUIDING CATHETER because a subset may experience extensive loss of primary segment material, 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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. The defect involves structural failure (material loss exposing wires) in a medical device used for cardiovascular procedures, indicating a significant risk of injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has announced a Class I recall involving the SHERPA NX ACTIVE GUIDING CATHETER, specifically the 6F, JL3.5, 110CM, 070" model with reference number SA6JL35A. The 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. All lot and serial numbers associated with GTIN 00613994822222 are included.
Medtronic Vascular is conducting this recall because there is a potential for extensive loss of primary segment material on a subset of these catheters. This defect exposes the underlying stainless-steel braid wires, which poses a risk to patients using the device.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. 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: 00613994822222 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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