Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters
Medtronic Vascular is recalling 53 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, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Vascular is recalling 53 units of the Sherpa NX Active Guiding Catheter, 6F, IMA, 90CM, 070", REF SA6IMAD, for cardiovascular use. The recall is due to a potential for extensive loss of primary segment material on a subset of these catheters, which could expose the underlying stainless-steel braid wires.
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 applies to all lot and serial numbers for the GTIN 00613994824066.
Healthcare providers and facilities should stop using the affected catheters and contact Medtronic Vascular for further instructions. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 90CM, 070", REF SA6IMAD . for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 53
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: 00613994824066 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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