CLASS II Device recall · Reported 4 May 2022 · FDA Enforcement Report

Empower Introducer Sheath with Hydrophilic Coating 21F recalled

Freudenberg Medical is recalling Empower Introducer Sheath with Hydrophilic Coating 21F, distributed in Georgia. The recall was initiated on 21 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: PD02, PD00013142 UDI: 00802526618000

Quantity recalled8 units (OUS)

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-1017-2022
FDA event ID: 89882
Recalling firm: Freudenberg Medical, Jeffersonville, IN
Classification: Class II
Status: Terminated
Recall initiated: 21 Feb 2022
FDA classified: 28 Apr 2022
Reported: 4 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

21 Feb 2022	Recall initiated by company
28 Apr 2022	Classified by FDA	+66 days
4 May 2022	Published in enforcement report	+6 days

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

Reason for recall

Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia

Product as listed by the FDA

Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)

Where it was distributed

US distribution: GA, OH Foreign distribution: Netherlands

Georgia

Questions about this recall

Why was it recalled?

Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia

Which lots are affected?

Lot Numbers: PD02, PD00013142 UDI: 00802526618000

Where was it sold?

US distribution: GA, OH Foreign distribution: Netherlands

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 89882

This product is part of a recall event; the main page for the event is Empower Introducer Sheath with Hydrophilic Coating 21F recalled.

Reported	Class	Recall	Company	Reason	Where
4 May 2022	CLASS II	Empower Introducer Sheath with Hydrophilic Coating 21F recalled	Freudenberg Medical	Other	GA

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