Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 55 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
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I. According to the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical) regardless of other factors.
Plain-English summary
Medtronic Vascular is recalling 55 units of the Sherpa NX Active Guiding Catheter, 6F, RBU3.5 SH, 100CM, 070", REF SA6RBU35SH. The recall affects all lot and serial numbers for this specific product configuration, identified by GTIN 00613994822970.
The recall was initiated because there is a potential for extensive loss of primary segment material on a subset of these 6F Sherpa catheters. This defect could result in the exposure of underlying stainless-steel braid wires. The agency has classified this recall as Class I, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The affected products were distributed worldwide to the United States, Austria, Belgium, Bulgaria, the Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, the Netherlands, Poland, Portugal, the Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and the United Kingdom. Healthcare providers and facilities should check their inventory for this specific reference number and stop using the affected devices.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5 SH, 100CM, 070", REF SA6RBU35SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 55
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: 00613994822970 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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