Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femo
FDA device recall Z-2039-2020 · posted 2020-05-27 · Terminated
Recall details
- Recalling firm
- Medtronic Vascular Galway DBA Medtronic Ireland
- Reason for recall
- Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 103 units
- Distribution
- US distribution in TX, WI, CA, NY, AL, and MI.
- Date initiated
- 2020-05-12
- Date posted
- 2020-05-27
- Date terminated
- 2022-03-10
- Location
- Galway, Ireland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| transGlideXT Expandable Introducer (K181817) | Transaortic Medical, Inc. | 2019-03-26 |