Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 105 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 recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric. The hazard involves the exposure of stainless-steel braid wires, a significant structural defect in a medical device.
Plain-English summary
Medtronic Vascular is recalling 105 units of the Sherpa NX Active Guiding Catheter, 6F JR5.0 SH, .070" (Reference SA6JR50SH), for cardiovascular use. The recall affects all lot and serial numbers, identified by GTIN 00613994821799.
The recall is being conducted 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 affected devices 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. Healthcare providers and facilities should stop using the affected devices and contact Medtronic Vascular for further instructions.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F JR5.0 SH, .070", REF SA6JR50SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 105
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: 00613994821799 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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