Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 3 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 source text explicitly identifies this as a Class I recall. According to the rubric, FDA Class I recalls are classified as Severe (Score 4) or Critical (Score 5). Since no reported deaths or serious injuries are mentioned in the source text, the score is 4.
Plain-English summary
Medtronic Vascular is recalling 3 units of the Sherpa NX Active Guiding Catheter, 6F 110CM AL20, reference SA6AL20A. The recall affects all lot and serial numbers for this specific product configuration.
The recall was initiated because there is a potential for extensive loss of primary segment material, which could expose underlying stainless-steel braid wires on a subset of the 6F Sherpa catheters. This is a Class I recall, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The affected products 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 patients should stop using the affected catheters and contact Medtronic Vascular for further instructions.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F 110CM AL20, REF SA6AL20A. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 3
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: 00613994823724 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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