Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters
Medtronic Vascular is recalling 4 units of Sherpa NX Active Guiding Catheters due to 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 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. Per 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 four units of the Sherpa NX Active Guiding Catheter, 6F, Noto SH, 100cm, 070" (Reference SA6NOTOSH). The device is intended for cardiovascular use and is identified by GTIN 00613994823014. The recall covers all lot and serial numbers for this specific configuration.
The recall is being issued because there is a potential for extensive loss of primary segment material on a subset of these catheters. This defect could expose the underlying stainless-steel braid wires. 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 U.S. Food and Drug Administration has classified this as a Class I recall. Healthcare providers and patients should stop using the affected devices and contact Medtronic Vascular for further instructions or replacement.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO SH, 100CM, 070", REF SA6NOTOSH. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 4
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: 00613994823014 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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Same hazard · material loss
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 Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
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- SevereMedtronic Vascular Recalls Sherpa NX Active Guiding Catheters
FDA (Devices) · 2019-10-09
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