Concentric Medical Inc: Medical Device Recall in 2014 - (Recall #: Z-0528-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 13, 2013

Date Posted: December 17, 2014

Recall Number: Z-0528-2015

Event ID: 69799

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.

Status: Terminated

Product Quantity: 10 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated