Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 5 units of Sherpa NX Active Guiding Catheters because a defect may 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 as a Class I recall, which mandates a minimum severity score of 4 per the rubric, as it indicates a reasonable probability of serious adverse health consequences.
Plain-English summary
Medtronic Vascular is recalling 5 units of the Sherpa NX Active Guiding Catheter, 6F, CHAMP2.0, 55CM.070" (Reference SA6CHAMP20K). The recall is due to a potential for extensive loss of primary segment material, which could expose underlying stainless-steel braid wires on a subset of these catheters.
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 00613994823359.
Healthcare providers and patients should stop using the affected catheters and contact Medtronic Vascular for instructions on return or replacement. The FDA has classified this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP2.0, 55CM.070", REF SA6CHAMP20K. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 5
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: 00613994823359 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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