Medtronic Sherpa NX Active Guiding Catheter Recalled for Material Loss
Medtronic Vascular is recalling specific Sherpa NX Active Guiding Catheters 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 poses a risk of harm (exposure of stainless-steel wires) 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 the Sherpa NX Active Guiding Catheter, 6F JR4.0 SH, 110CM, .070" REF SA6JR40SHA, for cardiovascular use. The recall affects 1 unit per lot, with all lot serial numbers included under GTIN 00613994821843.
The recall is issued because there is a potential for extensive loss of primary segment material on a subset of these 6F Sherpa catheters. This defect could result in the exposure of underlying stainless-steel braid wires.
The product 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. Healthcare providers and patients should contact Medtronic Vascular for further instructions regarding the affected devices.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0 SH, 110CM, .070" REF SA6JR40SHA. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 1
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: 00613994821843 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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