Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 10 units of Sherpa NX Active Guiding Catheters due to potential loss of primary segment material exposing 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 classified this recall as Class I, which mandates a minimum severity score of 4 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Medtronic Vascular is recalling 10 units of the Sherpa NX Active Guiding Catheter, 6F CHAMP1.0 SH, .070", reference number SA6CHAMP10SH. The product is intended for cardiovascular use. The recall covers all lot and serial numbers for the GTIN 00613994823403.
The recall was initiated because there is a potential for extensive loss of primary segment material on a subset of these 6F Sherpa catheters. This defect may expose underlying stainless-steel braid wires. The agency has classified this recall as Class I.
The affected units were distributed worldwide to the United States, Austria, Belgium, Bulgaria, the Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, the Netherlands, Poland, Portugal, the Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and the United Kingdom. Users should contact Medtronic Vascular for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0 SH, .070", REF SA6CHAMP10SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 10
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: 00613994823403 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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