Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss
Medtronic Vascular is recalling 246 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
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect that could expose sharp stainless-steel wires, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Medtronic Vascular is recalling 246 units of the Sherpa NX Active Guiding Catheter, 6F 100CM 3DRC, reference number SA63DRCSH. The recall affects all lot and serial numbers for the product, which is intended for cardiovascular use.
The recall was initiated because there is a potential for extensive loss of primary segment material on a subset of the 6F Sherpa catheters. This defect could expose the underlying stainless-steel braid wires. The product was distributed worldwide to the United States and 24 other countries, including Austria, Belgium, France, Germany, and the United Kingdom.
Healthcare providers and facilities that have received these devices should stop using them and contact Medtronic Vascular for instructions on return or replacement. Consumers should not use the recalled catheters and should consult their healthcare provider if they have questions regarding the recall.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F 100CM 3DRC, REF SA63DRCSH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 246
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: 00613994823816 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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