Perouse Flamingo — Class II medical device recall Z-2089-2014
Terminated recall by Perouse Medical, reported 2014-07-30. Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devic
| Recall number | Z-2089-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Perouse Medical, Irigny, France |
| Recall initiated | 2012-05-10 |
| Classified | 2014-07-22 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2014-09-09 |
| Quantity | 2,496 units |
| Lot numbers | 12021194, 12021401, 12021402, 12021403, 12021404, 12021405, 12021448, 12021449, 12021450, 12031237, 12031240, 12031241, 12031242, 12031244, 12031245, 12031246, 12031247, 12031248, 12031249, 12031275, 12031405, 12031460, 12031461, 12031462, 12031480, 12031497, 12031524, 12031525, 12031526, 12031527, 12041181, 12041183, 12041184, 12041185, 12041186, 12041344, 12041345 |
| Model numbers | 0218TA, 0218TB |
| Expiration dates | 2017-02 |
Product
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2089-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.