Medtronic Confida Expandable Sheath Recalled for Vascular Complication Risk
Medtronic is recalling 103 units of the Confida Expandable Sheath due to an increased risk of vascular complications, including bleeding, hematoma, and dissection.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)"
Plain-English summary
Medtronic Vascular Galway DBA Medtronic Ireland is recalling 103 units of the Medtronic Confida Expandable Sheath, reference number CES122230. The device is used to provide a guide for catheters or other devices introduced into the femoral iliac arteries. The recall covers all lot numbers associated with UDI 00763000233815.
The recall was initiated because of an increased risk of events associated with vascular complications, specifically bleeding, hematoma, and dissection. The affected units were distributed in the United States to Texas, Wisconsin, California, New York, Alabama, and Michigan.
Healthcare providers and facilities that have received these devices should stop using them immediately and contact Medtronic for instructions on how to return the product.
The recalled product
- Product
- Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
- Manufacturer
- Medtronic Vascular Galway DBA Medtronic Ireland
- Affected units
- 103
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 (2)
- UDI: 00763000233815
- All Lot Numbers
Distribution
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