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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of serious vascular complications (bleeding, hematoma, dissection), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
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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