CLASS II Device recall · Reported 17 Dec 2014 · FDA Enforcement Report

Trevo Pro 4 Stent Retriever recalled by Concentric Medical

Concentric Medical is recalling Trevo Pro 4 Stent Retriever, distributed in Alabama, California, Indiana, New Jersey, Pennsylvania. The recall was initiated on 13 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number/Expiration date: Lot Number 36774: March 2015 Lot Number 36432: December 2014 Lot Number 36757: March 2015 Lot Number 36761: March 2015

Quantity recalled10 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-0528-2015
FDA event ID: 69799
Recalling firm: Concentric Medical, Mountain View, CA
Classification: Class II
Status: Terminated
Recall initiated: 13 Nov 2013
FDA classified: 8 Dec 2014
Reported: 17 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Processing Deviation
Device type: Heart & Vascular Devices

Timeline

13 Nov 2013	Recall initiated by company
8 Dec 2014	Classified by FDA	+390 days
17 Dec 2014	Published in enforcement report	+9 days

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

Reason for recall

Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Where it was distributed

US Distribution to states of: CA, IN, PA, AL, and NJ.

Alabama California Indiana New Jersey Pennsylvania

Questions about this recall

Is Trevo Pro 4 Stent Retriever recalled?

Yes. Concentric Medical recalled Trevo Pro 4 Stent Retriever on 13 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0528-2015.

Why was it recalled?

Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.

Which lots are affected?

Lot number/Expiration date: Lot Number 36774: March 2015 Lot Number 36432: December 2014 Lot Number 36757: March 2015 Lot Number 36761: March 2015

Where was it sold?

US Distribution to states of: CA, IN, PA, AL, and NJ.

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 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.

More recalls from Concentric Medical

All 5

Reported	Class	Recall	Company	Reason	Where
21 Oct 2015Device	CLASS II	Distal Access Catheters - 044 -: Finished Good Number recalled	Concentric Medical	Other	KY
17 Dec 2014Device	CLASS II	Distal Access Catheter recalled by Concentric Medical	Concentric Medical	Other	17 states
17 Sep 2014Device	CLASS II	Merci Retriever Intended to restore blood flow recalled	Concentric Medical	Other	5 states
16 Jan 2013Device	CLASS II	FlowGate Balloon Guide Catheter recalled by Concentric Medical	Concentric Medical	Other	Nationwide

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