The Recall Desk

FDA (Devices) recall action 92446

Maquet Cardiovascular, LLC recalled 4 products on 2023-08-09

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2023-08-09
Critical
0
Units
2,114

Why these products were recalled

The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • HighFDA (Devices)··2023-08-09

    ACROBAT-i Vacuum Stabilizer Blade Latching Failure in Cardiac Surgery Systems

    A latching mechanism in the ACROBAT-i Vacuum Stabilizer System may fail during cardiac surgery, potentially causing loss of heart stabilization or device component release. The defect affects 334 units distributed worldwide.

    Product
    ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-08-09

    Cardiac Surgery Device Blade May Fail to Latch Securely During Use

    The ACROBAT SUV blade may not latch securely onto its activator drive during use. This could prevent heart stabilization during surgery, cause positioning loss, or release device components into the patient.

    Product
    ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-08-09

    Chest Stabilization Device Latch May Fail During Cardiac Surgery

    The ACCESSRAIL Platform Standard Blade may fail to latch securely, potentially causing loss of heart stabilization or device component release into patients during cardiac surgery.

    Product
    ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-08-09

    ACROBAT V Cardiac Stabilization System may fail to secure during surgery

    A latch defect in the ACROBAT V Vacuum Off-Pump System may prevent proper heart stabilization during cardiac surgery. Maquet Cardiovascular recalled 594 units distributed worldwide.

    Product
    ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
    Category
    Distribution
    0 states