Medtronic Recalls 6F Sherpa NX Active Guiding Catheters
Medtronic Vascular is recalling 4 units of 6F 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 according to the rubric, as it indicates a reasonable probability that the use of the product will cause serious adverse health consequences.
Plain-English summary
Medtronic Vascular is recalling 4 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR3.0, 100CM, 070" (REF SA6SR30). The recall is associated with the GTIN 00613994822819 and applies to all lot and serial numbers for this specific reference.
The recall is being 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 is intended for cardiovascular use.
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 source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR3.0, 100CM, 070", REF SA6SR30. 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: 00613994822819 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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