Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 3 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
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.
Plain-English summary
Medtronic Vascular is recalling three units of the Sherpa NX Active Guiding Catheter, 6F RCBII, .070" (Reference SA6RCBII), for cardiovascular use. 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 these 6F catheters.
The affected products 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 applies to all lot and serial numbers for the GTIN 00613994822895.
Healthcare providers and facilities should stop using the affected catheters and contact Medtronic Vascular for instructions on return or replacement. Consumers should not use these medical devices and should contact their healthcare provider if they have questions regarding the recall.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F RCBII, .070", REF SA6RCBII. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 3
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: 00613994822895 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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