Medtronic Recalls Sherpa NX Active Guiding Catheters for Structural Defect
Medtronic Vascular is recalling 4 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 involves a structural vehicle defect (loss of segment material exposing wires) in a medical device, which meets the criteria for a Severe rating (Score 4) due to the risk of significant injury.
Plain-English summary
Medtronic Vascular is recalling four units of the Sherpa NX Active Guiding Catheter, 6F ECR4.0 SH, .070" (REF SA6ECR40SH), for cardiovascular use. 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 6F Sherpa 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 applies to all lot and serial numbers for the GTIN 00613994824813.
Healthcare providers and consumers should stop using the affected catheters and contact Medtronic Vascular for further instructions on the recall.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0 SH, .070", REF SA6ECR40SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 4
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: 00613994824813 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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