Medtronic Recalls SHERPA NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 3 units of SHERPA NX Active Guiding Catheters because primary segment material may be lost, exposing 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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, which mandates a score of 5 per the rubric.
Plain-English summary
Medtronic Vascular is recalling 3 units of SHERPA NX Active Guiding Catheters, 6F LCB 90CM, .070" (REF SA6LCBD), for cardiovascular use. The recall is due to a potential for extensive loss of primary segment material, which may expose underlying stainless-steel braid wires on a subset of these 6F Sherpa catheters.
The affected product is identified by GTIN 00613994821706 and includes all lot and serial numbers. The product was distributed worldwide to the US, 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 U.S. Food and Drug Administration has classified this as a Class I recall. Consumers and healthcare providers should stop using the affected devices and contact Medtronic Vascular for further instructions.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 3
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: 00613994821706 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.
See all 191 products in this recall →Related recalls
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See all →- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
FDA (Devices) · 2019-10-09
- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
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- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
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- SevereMedtronic Vascular Recalls Sherpa NX Active Guiding Catheters
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