FDA Medical Device Recalls (openFDA)
Maquet Datascope Corp - Cardiac Assist Division: Cardiosave Hybrid and rescue IABP
- Recall number
- Z-1248-2016
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division
- Product
- Cardiosave Hybrid and rescue IABP
- Status
- Terminated
- Initiated
- 2015-12-16
- Posted
- not on file
- Terminated
- 2018-06-01
- Reason
- Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.
- Root cause
- Other
- Action
- Maquet sent an "Urgent - Medical Device Field Correction Notice and Response form dated December 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are informed of the issues and provided corrective actions. Customers are asked to completed the attached response form in order to return to 1-973-629-1518, or via email to cardiosavescroll@maquet.com. Questions can be directed 1-800-777-4222, option 3, Monday through Friday 8 am-6 pm. EST.
- Quantity
- 1243 units US; 1107 units OUS
- Distribution
- Worldwide Distribution- Nationwide Distribution including Puerto Rico.
- Lot, serial or model codes
- Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83
- 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