Z-0528-2015Class II

Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to...

Name: Z-0528-2015 Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to...
Creator: Concentric Medical Inc
Published: 2013-11-13
License: https://open.fda.gov/license/

Concentric Medical, Inc. / initiated 2013-11-13 / Terminated / root cause: manufacturing process

FDA source

Concentric Medical Inc began a recall of 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... on 2013-11-13. FDA classified it as Class II and gives the reason as "Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0528-2015
Classification: Class II
Status: Terminated
Initiated: 2013-11-13
Posted: 2014-12-08
Terminated: 2014-12-08
Recalling firm: Concentric Medical, Inc.
Product: 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.
Product code: NRY Catheter, Thrombus Retriever
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Concentric Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated November 18, 2013 to all affected customers by traceable mail. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately locate the subject devices and quarantine them; distribute this notice to all affected departments in your facility; inform Concentric Medical (Stryker Neurovascular) if any of the subject devices have been distributed to other organizations; complete, sign and return the attached Customer Response Form via fax to: 1-866-876-4355 or email a copy to: [email protected], even if you do not have any subject devices to return, and keep a copy of the completed, signed Customer Response Form for your records. Should you have any queries concerning this matter, please do not hesitate to contact the QA Manager at 650-810-1716.
Quantity in commerce: 10 units
Distribution: US Distribution to states of: CA, IN, PA, AL, and NJ.
Product codes and lots: Lot number/Expiration date: Lot Number 36774: March 2015 Lot Number 36432: December 2014 Lot Number 36757: March 2015 Lot Number 36761: March 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0528-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0528-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08

Product code NRY

K120961Class IITrevo RetrieverConcentric Medical, Inc. / cleared 2012-08-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)