FDA Medical Device Recalls (openFDA)
Perouse Medical: Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
- Recall number
- Z-2089-2014
- 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.
- Status
- Terminated
- Initiated
- 2012-05-10
- Posted
- 2014-07-22
- Terminated
- 2014-09-09
- 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.
- 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
- 2,496 units
- Distribution
- US.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K082755"]
- PMA numbers
- not on file
- Product code
- MAV
- Firm FEI
- 3004160911
- Firm city
- Irigny
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28