Class II — Perouse Medical
| Recalling firm | Perouse Medical |
|---|---|
| Registered facility | Perouse Medical (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | 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 |
| Distribution | US. |
| Initiated | 2012-05-10 |
| Classified | 2014-07-22 |
| Terminated | 2014-09-09 |
| Recall number | Z-2089-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Perouse Medical (Z-2089-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68795/
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