Medtronic Recalls Six Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter because of a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class I. According to the severity rubric, an FDA Class I recall must be scored as at least 4 (Severe), regardless of whether specific injuries are reported in the text.
Plain-English summary
Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter, 6F HSIII SH, .070", REF SA6HSIIISH. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-2693-2019.
The recall is due to a potential for extensive loss of primary segment material on a subset of these 6F Sherpa catheters. This defect could expose the underlying stainless-steel braid wires. The agency has classified this as a Class I recall.
The affected units 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. The source text does not specify specific lot or serial numbers, noting instead that the GTIN is 00613994824141 and applies to all lot/serial numbers for this specific reference. Healthcare providers and consumers should contact Medtronic Vascular for further instructions on how to handle or return the affected devices.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII SH, .070", REF SA6HSIIISH. 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: 00613994824141 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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