Z-2089-2014Class II

Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create...

Name: Z-2089-2014 Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create...
Creator: Perouse Medical
Published: 2012-05-10
License: https://open.fda.gov/license/

Perouse Medical / initiated 2012-05-10 / Terminated / root cause: manufacturing process

FDA source

Perouse Medical began a recall of Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter on 2012-05-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2089-2014
Classification: Class II
Status: Terminated
Initiated: 2012-05-10
Posted: 2014-07-22
Terminated: 2014-09-09
Recalling firm: Perouse Medical
Product: Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Product code: MAV Syringe, Balloon Inflation
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Perouse Medical initiated this recall by sending an e-mail notification to consignees on May 10, 2012. A formal written recall notification letter was sent to consignees on May 16, 2012. The recall letter, written in English, on company's letterhead, dated May 16, 2012, titled "VOLUNTARY BATCH RECALL Of FLAMINGO Inflations Devices", notified the consignee of the following: product information with codes and batch codes, product description, description of the potential default, reason for the recall action, instructions to the consignee, contact information and assistance. Response form "INVENTORY FORM".
Quantity in commerce: 2,496 units
Distribution: US.
Product codes and lots: Model 0218TA and 0218TB. Manufacturing Lot Numbers: 12031275 and 12031242. EXP.: 02/2017. Batches: 12031526, 12031249, 12031527, 12031248, 12041183, 12041186, 12031244, 12031461, 12031460, 12021404, 12031462, 12031245, 12021405, 12031405, 12031246, 12021401, 12041344, 12031237, 12031241, 12021403, 12041345, 12041184, 12031497, 12031240, 12021194, 12031524, 12031480, 12041181, 12031275, 12031242, 12021450, 12021449, 12041185, 12031525, 12031247, 12021402, 12021448.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2089-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2089-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22

Product code MAV

K082755Class IISedat FlamingoSedat / cleared 2008-12-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)