Z-0099-2019 Class I Ongoing
FDA device recall Z-0099-2019 was initiated by Maquet Datascope Corp - Cardiac Assist Division on September 20, 2018 and is designated Class I. Reason for recall: 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. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- November 7, 2018
- Initiation Date
- September 20, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Reason for Recall
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.
Distribution Pattern
US Nationwide; Internationally to 77 countries
Code Information
UDI - 10607567108391 All Serial Numbers