Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 51 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
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
Medtronic Vascular is recalling 51 units of the Sherpa NX Active Guiding Catheter, 6F JL4.5 SH, .070" (Reference SA6JL45SH), intended for cardiovascular use. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-2686-2019.
The recall is issued because there is a potential for extensive loss of primary segment material on a subset of these catheters. This defect could expose the underlying stainless-steel braid wires. The agency has classified this recall as Class I.
The affected units were distributed worldwide to the United States, Austria, Belgium, Bulgaria, the Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, the Netherlands, Poland, Portugal, the Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and the United Kingdom. All lot and serial numbers are affected, with the GTIN 00613994822086. Healthcare providers should stop using the affected devices and contact Medtronic Vascular for further instructions.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5 SH, .070", REF SA6JL45SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 51
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: 00613994822086 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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