Facility

Edwards Lifesciences Holding B.V.

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

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3042941992
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	CENTERPOINT 1, 4TH FLOOR AMSTERDAM Noord-Holland, NL 1101 BE
Registration status	Active · expires 2026
Parent company	Becton, Dickinson and Company (owner-operator 10093301)
Brand names	Nexfin; Nexfin_HD

Activity by year

Recalls (2)

Devices registered here (2)

System, Measurement, Blood-Pressure, Non-Invasive
Product code DXN (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1130
Plethysmograph, Impedance
Product code DSB (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2770

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.

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. “Edwards Lifesciences Holding B.V. (FEI 3042941992) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3042941992-edwards-lifesciences-holding-b-v/

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