Recall Z-2039-2020 ยท DYB Introducer, Catheter
Medtronic Vascular Galway DBA Medtronic Ireland
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
| Date | May 27, 2020 (initiated May 12, 2020) |
| Status | Terminated |
| Reason | Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection) |
| Root cause | Process control |
| Action | 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. |
| Quantity | 103 units |
| Distribution | US distribution in TX, WI, CA, NY, AL, and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181817 | transGlideXT Expandable Introducer Transaortic Medical, Inc., Mar 26, 2019 |