Facility

Perouse Medical

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

Key facts

3recalls · worst Class II

1inspections · worst NAI

—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)	3006942524
Establishment type	Manufacture Medical Device
Location	Route du Manoir FRANCE Oise, FR 60173
Registration status	Active · expires 2026
Parent company	Perouse Medical (owner-operator 10024483)
Brand names	Dolphin Inflation Device

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (1)

Syringe, Balloon Inflation
Product code MAV (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1650

Recalls & enforcement

Class IITerminated2017-04-05
Complaints regarding broken blister.
Class IITerminated2014-10-06
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
Class IITerminated2012-05-10
Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential water-tightness default. The potential default could cause an air entry when the plunger is positioned around 20 mL.

FDA inspections (1)

NAI2018-07-18
No Action Indicated · Compliance: Devices

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.

All facilities operated by Perouse Medical

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. “Perouse Medical (FEI 3006942524) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006942524-perouse-medical/

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