RegWardenFDA facility compliance records
Facility

CardioQuip

4 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2016: 1 inspections; 2021: 2 recalls, 1 inspections; 2022: 1 warning letters; 2023: 2 recalls120162017201820192020320211202222023202420252026
  • Recalls (4)
  • Inspections (2)
  • Warning letters (1)

Devices registered here (1)

  • Controller, Temperature, Cardiopulmonary Bypass
    Product code DWC (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.4250

Recalls & enforcement

  • Class IIOngoing2023-10-24
    There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
  • Class IIOngoing2023-10-19
    There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
  • Class IIOngoing2021-06-24
    There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.
  • Class IIOngoing2021-05-12
    Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

FDA inspections (2)

  • OAI2021-09-17
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2016-08-09
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CardioQuip (FEI 3007899424) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007899424-cardioquip/

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