Confida recallZ-2039-2020 · Medtronic Vascular Galway DBA Medtronic Ireland · initiated May 12, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Vascular Galway DBA Medtronic Ireland or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
FDA root cause category: Process control
What the company is doing
The firm initiated the recall on 05/12/2020 by letter. The notice instructed the consignee to quarantine the product and return it to Medtronic.
Recall details
- Recall number
- Z-2039-2020
- Status
- Terminated
- Initiated by the company
- May 12, 2020
- Posted by the FDA
- May 27, 2020
- Recalling firm
- Medtronic Vascular Galway DBA Medtronic Ireland
- Quantity
- 103 units
- Product code
- DYB
- FDA submissions
- K181817
- Distribution
- US distribution in TX, WI, CA, NY, AL, and MI.
Product description
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Code information (models, lots, serial numbers)
UDI: 00763000233815, All Lot Numbers
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Confida™ CES122230Medtronic, Inc. · INTRODUCER, CATHETER1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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