The Recall Desk

Manufacturer

Acist Medical Systems

3 recalls in our database name Acist Medical Systems as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2021-03-10

Of the 3 recalls from Acist Medical Systems 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.

1–3 of 3

  • HighFDA (Devices)·Z-1161-2021·2021-03-10

    ACIST Kodama Intravascular Ultrasound Catheter Recalled for Damaged O-Ring

    Acist Medical Systems is recalling Kodama Intravascular Ultrasound Catheters because damaged o-ring fragments could be flushed out of the device.

    Product
    ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultraso
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0744-2016·2016-02-10

    Acist Medical Systems Recalls BT2000 and CPT2000 Automated Manifold Kits

    Acist Medical Systems is recalling BT2000 and CPT2000 Automated Manifold Kits due to reports of air ingress into the manifold.

    Product
    ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and d
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1145-2013·2013-04-24

    ACIST Angiographic Injection System Recall for Air Ingress

    Acist Medical Systems is recalling 6,640 units of BT2000 Automated Manifold Kits due to air ingress into the manifold body.

    Product
    ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide