RegWardenFDA facility compliance records
Facility

CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG

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

Activity by year

FDA actions on record by year2026: 2 recalls20172018201920202021202220232024202522026
  • Recalls (2)

Devices registered here (1)

  • Transducer, Blood-Pressure, Extravascular
    Product code DRS (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2850

Recalls & enforcement

  • Class IIOngoing2026-08-11
    Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
  • Class IIOngoing2026-04-08
    Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

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. “CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG (FEI 3003081151) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003081151-cct-critical-care-technologies-s-r-l-als/

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