Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Perouse Flamingo Recalled by Perouse Medical Due to Perouse Medical in France initiated a voluntary recall...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Perouse Medical directly.
Affected Products
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Quantity: 2,496 units
Why Was This Recalled?
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.
Where Was This Sold?
US.
About Perouse Medical
Perouse Medical has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report