Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 488 units of Sherpa NX Active Guiding Catheters because a defect may expose 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 according to the rubric.
Plain-English summary
Medtronic Vascular is recalling 488 units of the Sherpa NX Active Guiding Catheter, 6F EBU3.75 SH, .070", reference SA6EBU375SH. The recall covers all lot and serial numbers for the product, identified by GTIN 00613994823540.
The recall was initiated because there is a potential for extensive loss of primary segment material, which could expose the underlying stainless-steel braid wires on a subset of the 6F Sherpa catheters. The product is intended for cardiovascular use.
The affected units 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. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for this recall.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75 SH, .070", REF SA6EBU375SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 488
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: 00613994823540 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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