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Terminated

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

FDA Recall Z-2039-2020 · Posted 2020-05-27

Recalling FirmMedtronic Vascular Galway DBA Medtronic Ireland
Recall StatusTerminated
Product CodeDYB
Date Initiated2020-05-12
Date Terminated2022-03-10
Product Quantity103 units

Reason for Recall

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

Firm 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.

Root Cause

Process control

Distribution Pattern

US distribution in TX, WI, CA, NY, AL, and MI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181817transGlideXT Expandable IntroducerTransaortic Medical, Inc. · 2019-03-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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