Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 49 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 according to the rubric mandates a minimum severity score of 4. Additionally, the defect involves structural failure (material loss exposing wires) in a medical device used for cardiovascular procedures, indicating a significant risk of serious injury.
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 JL3.0 SH, .070", REF SA6JL30SH, manufactured by Medtronic Vascular. This product is intended for cardiovascular use.
The recall was initiated because there is a potential for extensive loss of primary segment material on a subset of these catheters. This defect may expose the underlying stainless-steel braid wires, which poses a risk to patients during use.
A total of 49 units are affected. The distribution pattern includes worldwide distribution to the United States and numerous 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 00613994822253 and all lot/serial numbers.
Healthcare providers and patients should stop using the recalled catheters immediately. Medtronic Vascular is responsible for this recall action.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 49
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: 00613994822253 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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