Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 80 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 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 recall involves a structural defect in a medical device that exposes underlying stainless-steel braid wires, which poses a significant risk of injury during cardiovascular procedures.
Plain-English summary
Medtronic Vascular is recalling 80 units of the Sherpa NX Active Guiding Catheter, 6F JL3.5, .070", reference SA6JL355. The product is intended for cardiovascular use and was distributed worldwide to the United States and 24 other countries, including Austria, Belgium, and the United Kingdom.
The recall is due to 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 recall applies to all lot and serial numbers for the specific GTIN 20613994822233.
Healthcare providers and facilities should stop using the affected catheters and contact Medtronic Vascular for further instructions. Consumers should not use these medical devices and should contact their healthcare provider if they have questions about the recall.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL355. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Affected units
- 80
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: 20613994822233 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
Same manufacturer · Medtronic Vascular
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Same hazard · structural defect
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- Severe
- Severe
- Severe
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