Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 129 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 FDA Class I, which mandates a severity score of at least 4 per the rubric, and the defect involves structural integrity of a cardiovascular device.
Plain-English summary
Medtronic Vascular is recalling 129 units of the Sherpa NX Active Guiding Catheter, 6F EBU3.0 SH, .070" (Reference SA6EBU30SH), intended for cardiovascular use. The recall was initiated due to a potential for extensive loss of primary segment material, which may expose underlying stainless-steel braid wires on a subset of the affected 6F Sherpa catheters.
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. The recall includes all lot and serial numbers for the GTIN 00613994823601.
Healthcare providers and facilities should stop using the affected devices and contact Medtronic Vascular for instructions on return or replacement. Patients who have had these devices implanted should contact their healthcare provider to discuss the recall and any necessary follow-up care.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.0 SH, .070", REF SA6EBU30SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 129
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: 00613994823601 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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