Medtronic Recalls Six Sherpa NX Active Guiding Catheters for Material Loss
Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect that could expose sharp stainless-steel wires, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter, 6F ERAD Left SH, .070", reference number SA6ERADLSH. The recall affects all lot and serial numbers for this specific product configuration, identified by GTIN 00613994824738.
The recall is being conducted because there is a potential for extensive loss of primary segment material on a subset of these catheters. This defect could result in the exposure of underlying stainless-steel braid wires. 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. Healthcare providers and facilities should stop using the affected devices and contact Medtronic Vascular for further instructions.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT SH, .070", REF SA6ERADLSH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 6
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: 00613994824738 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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