CLASS II ONGOING Device recall · Reported 6 Sep 2023 · FDA Enforcement Report
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) recalled
Datascope is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, distributed nationwide in the US. The recall was initiated on 31 Jul 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2486-2023
- FDA event ID
- 92489
- Recalling firm
- Datascope, Mahwah, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Jul 2023
- FDA classified
- 30 Aug 2023
- Reported
- 6 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 31 Jul 2023 | Recall initiated by company | |
| 30 Aug 2023 | Classified by FDA | +30 days |
| 6 Sep 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65
Where it was distributed
US Nationwide. Global Distribution.
Questions about this recall
Is Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31 recalled?
Yes. Datascope recalled Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31 on 31 Jul 2023. The recall is Class II and its status is Ongoing. Recall number Z-2486-2023.
Why was it recalled?
Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
Which lots are affected?
All Lot Numbers. Model: 0998-00-0800-31, UDI: 10607567109053; Model: 0998-UC-0800-31, UDI: N/A; Model: 0998-00-0800-32,UDI: 10607567111117; Model: 0998-00-0800-33, UDI: 10607567109008; Model: 0998-UC-0800-33, UDI: N/A; Model: 0998-00-0800-34, UDI: 10607567111940; Model: 0998-00-0800-35, UDI: 10607567109107; Model: 0998-00-0800-45, UDI: 10607567108421;Model: 0998-00-0800-52, UDI: 10607567108438; Model: 0998-UC-0800-52, UDI: N/A; Model: 0998-00-0800-53, UDI:10607567108391; Model: 0998-UC-0800-53, UDI: N/A; Model: 0998-00-0800-55, UDI: 10607567108414; Model: 0998-UC-0800-55,UDI: N/A; Model: 0998-00-0800-65, UDI: 10607567113432; Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449
Where was it sold?
US Nationwide. Global Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Datascope
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|---|---|---|---|---|---|
| Device | CLASS III | Battery Charging Station recalled by Datascope | Datascope | Device Malfunction | Nationwide |
| Device | CLASS II | CS100 IABP recalled by Datascope | Datascope | Device Malfunction | Nationwide |
| Device | CLASS II | CS300 IABP recalled by Datascope | Datascope | Device Malfunction | Nationwide |
| Device | CLASS III | Cardiosave Hybrid recalled by Datascope | Datascope | Other | Nationwide |
| Device | CLASS III | Cardiosave Rescue recalled by Datascope | Datascope | Other | Nationwide |
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |