CLASS I Device recall · Reported 3 Jun 2020 · FDA Enforcement Report

Medtronic Confida Expandable Sheath recalled

Medtronic Vascular Galway is recalling Medtronic Confida Expandable Sheath, distributed in Alabama, California, Michigan, New York, Texas, Wisconsin. The recall was initiated on 12 May 2020 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI: 00763000233815, All Lot Numbers

Quantity recalled103 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2039-2020
FDA event ID: 85649
Recalling firm: Medtronic Vascular Galway, Galway, N/A
Classification: Class I
Status: Terminated
Recall initiated: 12 May 2020
FDA classified: 27 May 2020
Reported: 3 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

12 May 2020	Recall initiated by company
27 May 2020	Classified by FDA	+15 days
3 Jun 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Alabama California Michigan New York Texas Wisconsin

Questions about this recall

Is Medtronic Confida Expandable Sheath recalled?

Yes. Medtronic Vascular Galway recalled Medtronic Confida Expandable Sheath on 12 May 2020. The recall is Class I and its status is Terminated. Recall number Z-2039-2020.

Why was it recalled?

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

Which lots are affected?

UDI: 00763000233815, All Lot Numbers

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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