The Recall Desk

Manufacturer

Concentric Medical Inc

5 recalls in our database name Concentric Medical Inc as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2015-10-21

Of the 5 recalls from Concentric Medical Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • LowFDA (Devices)·Z-0116-2016·2015-10-21

    Concentric Medical Recalls One Distal Access Catheter for Distribution Error

    Concentric Medical Inc is recalling one Distal Access Catheter that was intended for distribution in Korea but was found at a US location in Kentucky.

    Product
    Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a se
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0528-2015·2014-12-17

    Concentric Medical Recalls Trevo Pro 4 Stent Retrievers Due to Labeling Error

    Concentric Medical is recalling 10 units of Trevo Pro 4 Stent Retrievers because they were shipped with non-U.S. instructions for use that did not align with U.S. indications.

    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
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0525-2015·2014-12-17

    Concentric Medical Recalls Distal Access Catheters Due to Incorrect Labeling

    Concentric Medical is recalling 87 Distal Access Catheters because they were shipped with Directions for Use containing instructions for aspiration, which are only approved outside the US.

    Product
    Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peri
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2598-2014·2014-09-17

    Merci Retriever Medical Devices Recalled for Expiration Date Issues

    Concentric Medical Inc is recalling nine Merci Retriever devices shipped past their expiration date. The devices were labeled with the correct expiration date but distributed to US customers after that date.

    Product
    Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the ne
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0655-2013·2013-01-16

    Concentric Medical Recalls FlowGate Balloon Guide Catheters Due to Tip Collapse

    Concentric Medical is recalling 13 FlowGate Balloon Guide Catheters after reports of resistance and possible distal tip collapse during use.

    Product
    FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal
    Category
    Medical Device
    Distribution
    Distributed nationwide