SHERPA NX Active Guiding Catheter recall due to exposed stainless-steel braid wires
A recall of Medtronic Vascular SHERPA NX active guiding catheters was issued because some units may expose underlying stainless-steel braid wires, posing a potential safety risk.
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 FDA Class I medical device with a potential safety issue (exposed stainless-steel braid wires). Per the severity rubric, FDA Class I classifications require a minimum severity score of 4, even when no actual injuries have been reported.
Plain-English summary
Medtronic Vascular issued a recall of its SHERPA NX active guiding catheters because testing revealed that a subset of these catheters may experience extensive loss of primary segment material, leading to the exposure of underlying stainless-steel braid wires. This potential safety issue could compromise the integrity of the device during use. Consumers who have received or are considering these catheters should consult their healthcare provider and follow the manufacturer's guidance regarding the recall. The worldwide distribution includes multiple countries, so all affected users should take action promptly.
The recalled product
- Product
- SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.5, .070", REF SA6SL45. for cardiovascular use
- Manufacturer
- Medtronic Vascular
- Category
- Medical Device — Guide Catheter
- Hazard
- Affected units
- 25
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: 00613994822475 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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