Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters
Medtronic Vascular is recalling 113 units of Sherpa NX Active Guiding Catheters due to a potential loss of material that could expose 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 classified this as an FDA Class I recall. Per the rubric, FDA Class I recalls are assigned a minimum score of 4 (Severe).
Plain-English summary
Medtronic Vascular is recalling 113 units of the Sherpa NX Active Guiding Catheter, 6F RRAD, .070" (REF SA6RRAD), intended for cardiovascular use. The recall was initiated because there is 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 covers all lot and serial numbers for the GTIN 00613994823205.
Healthcare providers and consumers should stop using the affected catheters and contact Medtronic Vascular for further instructions or replacement.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F RRAD, .070", REF SA6RRAD. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 113
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: 00613994823205 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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