Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 6 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
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 structural defect in a medical device that could expose sharp stainless-steel wires, posing a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter, 6F El Gamal SH, .070" (Reference SA6ELGAMALSH), for cardiovascular use. The recall is due to a potential for extensive loss of primary segment material, which could expose the underlying stainless-steel braid wires on a subset of these catheters.
The affected products 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 specific GTIN 00613994824776.
Healthcare providers and consumers should stop using the affected catheters and contact Medtronic Vascular for further instructions or a replacement.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL SH, .070", REF SA6ELGAMALSH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 6
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: 00613994824776 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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