FDA Medical Device Recalls (openFDA)
Maquet Datascope Corp - Cardiac Assist Division: Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
- Recall number
- Z-1140-2015
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division
- Product
- Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
- Status
- Terminated
- Initiated
- 2015-01-30
- Posted
- 2015-02-23
- Terminated
- 2017-09-29
- Reason
- Power supply malfunction complaints related to suboptimal thermal management.
- Root cause
- Under Investigation by firm
- Action
- Maquet Inc. sent a recall letter/return response form dated 1/30/2015.
- Quantity
- 1,300 units
- Distribution
- US Nationwide distribution
- Lot, serial or model codes
- 0998-00-0800-31 0998-UC-0800-31 0998-00-0800-32 0998-UC-0800-33 0998-00-0800-33 0998-UC-0800-52 0998-00-0800-34 0998-UC-0800-53 0998-00-0800-35 0998-UC-0800-55 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55. CARDIOSAVE Hybrid IABPs serviced with a new/replacement power supply after August 19, 2014 are not affected.
- 510(k) numbers
- ["K112372"]
- PMA numbers
- not on file
- Product code
- DSP
- Firm FEI
- 3001418283
- Firm city
- Mahwah
- 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