FDA Enforcement
Class I
Ongoing
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Recall: Z-0099-2019
·
Reported November 7, 2018
Enforcement
- Recall Number
- Z-0099-2019
- Event ID
- 81055
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Maquet Datascope Corp - Cardiac Assist Division
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Press Release
- Report Date
- November 7, 2018
- Initiation Date
- September 20, 2018
- Classification Date
- October 26, 2018
- Address
- 1300 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2052, United States
Description
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Reason
There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.
Code Info
UDI - 10607567108391 All Serial Numbers
Distribution
US Nationwide; Internationally to 77 countries
Quantity
N/A