FDA Medical Device Recalls (openFDA)
Cardiomedics Incorporated: Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000.
- Recall number
- Z-1582-2009
- Recalling firm
- Cardiomedics Incorporated
- Product
- Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000.
- Status
- Terminated
- Initiated
- 2009-04-09
- Posted
- 2009-07-07
- Terminated
- 2012-08-27
- Reason
- Cuff may underinflate, or device may stop working during use. Cardioassist software version 4.3.1 utilized a signal from the plethysmograph that was found not to be sensitive enough due to the shape of the waveform in certain circumstances where there was excessive motion artifact.
- Root cause
- Software design
- Action
- Service visit to customer in May 2009 to upgrade and validate CardioAssist 4000 software to version 4.3.5.
- Quantity
- 1
- Distribution
- Florida
- Lot, serial or model codes
- CardioAssist Model 4000 Serial 4018
- 510(k) numbers
- ["K050172"]
- PMA numbers
- not on file
- Product code
- DRN
- Firm FEI
- 2025845
- Firm city
- Irvine
- Firm state
- CA
- 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