Medtronic Recalls 14 Sherpa NX Active Guiding Catheters for Material Loss
Medtronic Vascular is recalling 14 units of Sherpa NX Active Guiding Catheters due to a potential loss of 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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. The defect involves the exposure of stainless-steel braid wires, a significant structural issue in a cardiovascular device.
Plain-English summary
Medtronic Vascular is recalling 14 units of the Sherpa NX Active Guiding Catheter, 6F HSII SH, .070" (REF SA6HSIISH), for cardiovascular use. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-2683-2019.
The recall is due to a potential for extensive loss of primary segment material on a subset of these 6F Sherpa catheters. This defect could expose the underlying stainless-steel braid wires. The affected units have the GTIN 00613994824134 and include all lot and serial numbers.
The 14 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. 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 HSII SH, .070", REF SA6HSIISH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 14
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: 00613994824134 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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