Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 2 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 medical device with a structural defect (exposed wires) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Vascular is recalling 2 units of the Sherpa NX Active Guiding Catheter, 6F, LCB SH, 90CM, 070", REF SA6LCBSHD. The product is intended for cardiovascular use and was 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 is due to a potential for extensive loss of primary segment material, which may expose underlying stainless-steel braid wires on a subset of the 6F Sherpa catheters. The recall covers all lot and serial numbers for the specific GTIN 00613994821676.
Healthcare providers and patients should contact Medtronic Vascular for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, LCB SH, 90CM, 070", REF SA6LCBSHD. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 2
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: 00613994821676 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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