Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 9 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 per the rubric mandates a minimum severity score of 4. Additionally, the defect involves structural failure (exposed wires) in a medical device used for cardiovascular procedures, posing significant injury risk.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has announced a Class I recall involving the SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0 SH, .070", REF SA6EBU50SH, manufactured by Medtronic Vascular. This product is intended for cardiovascular use.
The recall addresses a potential defect where a subset of these catheters may suffer extensive loss of primary segment material. This failure exposes the underlying stainless-steel braid wires within the device.
A total of 9 units are affected, identified by GTIN 00613994824592 and all associated lot or serial numbers. These 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.
Consumers or healthcare providers possessing these specific catheters should contact Medtronic Vascular for further instructions regarding the recall.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0 SH, .070", REF SA6EBU50SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 9
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: 00613994824592 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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