Balloon Catheter
Received Jul 27, 2026 · Event occurred Jul 5, 2026
Report 2248146-2026-0001326 · MDR key 50034598
Device
Generic name
System, Balloon, Intra-aortic And Control
Manufacturer
Datascope Corp.Product problems
- Pacing Problem
- Failure to Zero
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that during use, the Intra-Aortic Balloon was unable to zero and obtain blood pressure. Patient involved and no harm is reported. A Getinge Field Service Engineer (FSE) reported that issue on the pump cannot be duplicated.
Additional Manufacturer Narrative
E. Initial Reporter: (b)(6)Event Site Name: (b)(6) HOSPITALThe serial number for the medical device referred to in this medical device report has not been received, and therefore, no UDI number can be provided.Upon completion of the investigation into this event a follow up report will be submitted.