Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 82 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing 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 risk-of-harm medical device where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed adverse events.
Plain-English summary
Medtronic Vascular is recalling 82 units of the Sherpa NX Active Guiding Catheter, 6F HSII, .070", REF SA6HSII, for cardiovascular use. The recall is due to a potential for extensive loss of primary segment material, which may expose underlying stainless-steel braid wires on a subset of these 6F Sherpa catheters.
The affected products were distributed worldwide to the US, 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 recall applies to all lot and serial numbers for the GTIN 00613994824165.
Healthcare providers should stop using the affected catheters and contact Medtronic Vascular for further instructions. No specific illnesses or injuries are reported in the source text.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII, .070", REF SA6HSII. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 82
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: 00613994824165 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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