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Concentric Medical Recalls
5 recalls on record · January 16, 2013 to October 21, 2015 · Medical Devices
Recalls by year
13
14
15
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 21, 2015Medical DevicesFDA
Concentric Medical Inc recalls Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Ca
Hazard: One Distal Access Catheter intended for distribution in Korea, was found at a US location.
December 17, 2014Medical DevicesFDA
Concentric Medical Inc recalls Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore
Hazard: Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.
December 17, 2014Medical DevicesFDA
Concentric Medical Inc recalls Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in
Hazard: Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US.
September 17, 2014Medical DevicesFDA
Concentric Medical Inc recalls Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing
Hazard: Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.
January 16, 2013Medical DevicesFDA
Concentric Medical Inc recalls FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate&amp
Hazard: Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.