Medtronic Sherpa NX Active Guiding Catheter Recalled for Material Loss
Medtronic Vascular is recalling 3 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 FDA classified this recall as Class I, which mandates a severity score of at least 4 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Medtronic Vascular is recalling 3 units of the Sherpa NX Active Guiding Catheter, 6F SL3.0, .070" (Reference SA6SL30), for cardiovascular use. The recall is due to 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, 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 00613994822543.
Healthcare providers and patients should stop using the affected catheters and contact Medtronic Vascular for further instructions. The U.S. Food and Drug Administration has classified this recall as Class I.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.0, .070", REF SA6SL30. 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: 00613994822543 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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