Medtronic Sherpa NX Active Guiding Catheter Recalled for Material Loss
Medtronic Vascular is recalling 4 units of 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 could expose sharp stainless-steel wires, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Medtronic Vascular is recalling four units of the Sherpa NX Active Guiding Catheter, 6F SR3.5 SH, .070" REF SA6SR35SH, for cardiovascular use. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-2614-2019.
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 expose the underlying stainless-steel braid wires. The source text does not report any specific injuries or illnesses associated with this defect.
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 recall covers all lot and serial numbers for the GTIN 00613994822789. Healthcare providers and patients should contact Medtronic Vascular for instructions on how to manage the affected devices.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5 SH, .070" REF SA6SR35SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 4
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: 00613994822789 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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