Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 152 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing 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 Class I, and the rubric states that if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
Medtronic Vascular is recalling 152 units of the Sherpa NX Active Guiding Catheter, 6F AL2.0 SH, .070" (REF SA6AL20SH), for cardiovascular use. The recall affects all lot and serial numbers for the GTIN 00613994823717.
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 the underlying stainless-steel braid wires.
The affected devices 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. The source text does not specify instructions for consumers or healthcare providers regarding the handling of these devices.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0 SH, .070", REF SA6AL20SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 152
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: 00613994823717 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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