Medtronic Recalls SHERPA NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 10 units of SHERPA NX Active Guiding Catheters because a defect may 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 metal wires, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Vascular is recalling 10 units of SHERPA NX Active Guiding Catheters, reference SA6FR40, for cardiovascular use. The recall involves all lot and serial numbers for the specific GTIN 00613994824196.
The recall was initiated because there is a potential for extensive loss of primary segment material on a subset of these 6F catheters. This defect could expose the underlying stainless-steel braid wires.
The affected devices were distributed worldwide to the United States and 24 other countries, including Austria, Belgium, and the United Kingdom. Healthcare providers should stop using the affected catheters and contact Medtronic Vascular for instructions on return or replacement.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F FR4.0, .070", REF SA6FR40. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 10
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: 00613994824196 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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