Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 69 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
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 classification is Class I, and the rubric states that if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
Medtronic Vascular is recalling 69 units of the Sherpa NX Active Guiding Catheter, 6F EBU4.5 SH, .070" (REF SA6EBU45SH). The recall covers all lot and serial numbers for the GTIN 00613994824615. The product is intended for cardiovascular use.
The recall was initiated because there is a potential for extensive loss of primary segment material on a subset of the 6F Sherpa catheters. This defect may expose the underlying stainless-steel braid wires.
The affected units 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 source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5 SH, .070", REF SA6EBU45SH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 69
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: 00613994824615 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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