Medtronic Recalls Two Sherpa NX Active Guiding Catheters for Material Loss
Medtronic Vascular is recalling two units of the Sherpa NX Active Guiding Catheter 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 it represents a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Medtronic Vascular is recalling two units of the Sherpa NX Active Guiding Catheter, 6F, IMA SH, 60CM, 070" (REF SA6IMASHJ). The recall is due to a potential for extensive loss of primary segment material, which could expose the underlying stainless-steel braid wires on a subset of these 6F Sherpa catheters.
The affected product is intended for cardiovascular use. The recall covers all lot and serial numbers for the specific GTIN 00613994824424. The product was distributed worldwide to the US, 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.
Healthcare providers and consumers should stop using the affected catheters and contact Medtronic Vascular for further instructions or a replacement.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 60CM, 070", REF SA6IMASHJ. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 2
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: 00613994824424 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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