Concentric Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 46
- FDA recalls
- 8
At a glance
Market reach
- United States
- FDA recalls
What Concentric Medical, Inc. makes
Concentric Medical, Inc. manufactures neurovascular retrieval devices, including modified versions of the Trevo and Merci Retrievers, as well as microcatheters and guide catheters designed for clot removal in stroke treatment. These products are intended for use in mechanical thrombectomy procedures to retrieve blood clots from cerebral arteries. The portfolio also includes modified versions of microcatheters and guide catheters to support delivery and retrieval systems.
The company’s devices fall under FDA Class II regulation and are listed via 510(k) clearance. These products are intended for use in the United States, where the manufacturer is based.
Catalogue
Search and filter all 46 devicesFDA recalls
2015
- 19 Aug 2015 Z-0116-2016 Class II Terminated One Distal Access Catheter intended for distribution in Korea, was found at a US location.
2014
- 25 Jun 2014 Z-2598-2014 Class II Terminated Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.
2013
- 13 Nov 2013 Z-0528-2015 Class II Terminated Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.
- 26 Sep 2013 Z-0525-2015 Class II Terminated 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.
2012
- 20 Dec 2012 Z-0655-2013 Class II Terminated Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.
2009
- 27 Feb 2009 Z-0899-2011 Unclassified (pre-2012) Terminated Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.
Full distribution text
- 27 Feb 2009 Z-0899-2011 Unclassified (pre-2012) Terminated Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.
2003
- 24 Sep 2003 Z-0085-04 Unclassified (pre-2012) Terminated The device has the potential for tip breakage during use.
Full distribution text
- 24 Sep 2003 Z-0086-04 Unclassified (pre-2012) Terminated The device has the potential for tip breakage during use.
Full distribution text
- 24 Sep 2003 Z-0085-04 Unclassified (pre-2012) Terminated The device has the potential for tip breakage during use.
Frequently asked questions
How many devices does Concentric Medical, Inc. have in the registry?
The registry currently lists 46 devices for Concentric Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Concentric Medical, Inc.'s devices?
Among its 46 most recently registered devices, Concentric Medical, Inc. has devices listed in FDA 510(k) (46 devices).
What risk classes do Concentric Medical, Inc.'s devices fall under?
Among its 46 most recently registered devices, the classes recorded for Concentric Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Concentric Medical, Inc.?
FDA recall records list 8 recalls initiated by Concentric Medical, Inc., the most recent initiated on 19 Aug 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Concentric Medical, Inc. in the registry?
The most recently registered devices listed for Concentric Medical, Inc. include MODIFIED TREVO PROVUE RETRIEVER, MODIFIED CONCENTRIC MICROCATHETER, MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 and MODIFIED HD GUIDE CATHETER.