Recall Z-2039-2020— Medtronic Vascular Galway DBA Medtronic Ireland

Name: FDA recall Z-2039-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-12

Class I · Terminated

Class I FDA medical device recall by Medtronic Vascular Galway DBA Medtronic Ireland, initiated 2020-05-12, terminated 2022-03-10. It names one FDA 510(k) clearance: K181817. Product: Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.. Reason: Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection).

Recalling firm: Medtronic Vascular Galway DBA Medtronic Ireland
Classification: Class I
Status: Terminated
Initiated: 2020-05-12
Terminated: 2022-03-10
Firm location: Galway, N/A, Ireland

510(k) clearances named in this recall

1 on FDA's record

K181817 — transGlideXT Expandable IntroducerTransaortic Medical, Inc.·cleared 2019-03-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.

Reason for recall

Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)

Data sourced from openFDA. This site is unofficial and independent of the FDA.