FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular Us Sales, Llc: Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20.
- Recall number
- Z-1394-2011
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Product
- Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20.
- Status
- Terminated
- Initiated
- 2010-09-28
- Posted
- 2011-02-22
- Terminated
- 2011-08-11
- Reason
- A wrong ball bearing was installed in the pump heads of product. This may make the pump head wear out and cease function.
- Root cause
- Component change control
- Action
- Maquet hand delivered a letter to the consignee on 10/4/2010.
- Quantity
- 4 units
- Distribution
- One hospital in New York City
- Lot, serial or model codes
- Device Part Number (Model Number): 703309 Serial Numbers: 93202512, 93202514, 93202526, 93202527
- 510(k) numbers
- ["K943803"]
- PMA numbers
- not on file
- Product code
- DTQ
- 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