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Acist Medical Systems Recalls
3 recalls on record · April 24, 2013 to March 10, 2021 · Medical Devices
Recalls by year
13
16
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 10, 2021Medical DevicesFDA
Acist Medical Systems recalls ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the AC
Hazard: Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence.
February 10, 2016Medical DevicesFDA
Acist Medical Systems recalls ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, S
Hazard: Reports related to ingress of air into the manifold.
April 24, 2013Medical DevicesFDA
Acist Medical Systems recalls ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion
Hazard: ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection, and normally replacement of the BT2000 Automated Manifold Kit is necessary in order to proceed w