Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters
Medtronic Vascular is recalling specific 6F Sherpa NX Active Guiding Catheters due to a potential loss of 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 FDA classified this recall as Class I, which mandates a minimum severity score of 4 according to the rubric. The potential exposure of stainless-steel braid wires in a cardiovascular device represents a significant risk of injury.
Plain-English summary
Medtronic Vascular is recalling the SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070", REF SA6AL30A, which is used for cardiovascular procedures. The recall is being conducted because there is a potential for extensive loss of primary segment material on a subset of these catheters. This loss of material could expose the underlying stainless-steel braid wires.
The affected product is identified by GTIN 00613994824028 and includes all lot and serial numbers. The product was 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.
Healthcare providers and patients should stop using the affected catheters and contact Medtronic Vascular for further instructions. The FDA 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 recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070", REF SA6AL30A. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 1
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: 00613994824028 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
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
FDA (Devices) · 2019-10-09
- SevereMedtronic Vascular Recalls Sherpa NX Active Guiding Catheters
FDA (Devices) · 2019-10-09
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