Medtronic Recalls 18 Sherpa NX Active Guiding Catheters for Material Loss
Medtronic Vascular is recalling 18 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
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as this classification indicates a reasonable probability that the use of the product will cause serious adverse health consequences or death.
Plain-English summary
Medtronic Vascular is recalling 18 units of the Sherpa NX Active Guiding Catheter, 6F MB2 SH, .070" (REF SA6MB2SH), for cardiovascular use. The recall is being conducted because there is a potential for extensive loss of primary segment material on a subset of these 6F Sherpa catheters, which could expose the underlying stainless-steel braid wires.
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. The recall includes all lot and serial numbers for the GTIN 00613994821911.
Healthcare providers and facilities that have received these devices should stop using them and contact Medtronic Vascular for further instructions on the recall process.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F MB2 SH, .070", REF SA6MB2SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 18
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: 00613994821911 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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