FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular Us Sales, Llc: Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
- Recall number
- Z-0839-2013
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Product
- Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
- Status
- Terminated
- Initiated
- 2012-12-26
- Posted
- 2013-02-20
- Terminated
- 2014-05-08
- Reason
- ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.
- Root cause
- Nonconforming Material/Component
- Action
- Maquet sent Urgent Device Recall Letters/Recall Acknowledgement Forms to their customers on 12/26/2012.
- Quantity
- 41 units - US Distirbution; 216 units - OUS Distribution
- Distribution
- Worldwide Distribution-USA including the states of AZ, CO, FL, TN, and TX and the countries of Australia, Canada, Czech Republic, Dubai/Bahrain/Kuwait/Lebanon/Saudi Arabia/Yemen, France, Germany, Hong Kong, Italy, Japan, Netherlands, Singapore, South Africa, Sweden, Switzerland, Thailand, Turkey, and UK.
- Lot, serial or model codes
- US Distribution Part number 701017471 Lot numbers 92046825 92065723 92076940 OUS Distribution Part Number Lot Numbers 701002797 92050616 701002797 92052823 701002797 92052913 701002797 92058153 701002797 92063518 701002797 92068260 701002797 92069267 701002797 92072177 701002797 92075413 701002797 92077862 701005092 92081862 701005092 92049129 701005092 92070554 701005093 92049130 701005093 92056899 701005093 92065588 701005093 92069429 701005093 92070553 701005093 92071852 701005093 92073598 701005093 92076875 701017471 92076940 701046644 92063587 701050978 92047882 701050978 92053930 701050978 92054156 701050978 92056171 701050978 92056804 701050978 92065094 701050978 92067382 701050978 92068224 701050978 92069286 701050978 92071806
- 510(k) numbers
- ["K002857"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 3008355164
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
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