CLASS II ONGOING Device recall · Reported 6 Oct 2021 · FDA Enforcement Report
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) recalled by Datascope
Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), distributed nationwide in the US. The recall was initiated on 8 Sep 2021 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-2616-2021
- FDA event ID
- 88664
- Recalling firm
- Datascope, Mahwah, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Sep 2021
- FDA classified
- 30 Sep 2021
- Reported
- 6 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 8 Sep 2021 | Recall initiated by company | |
| 30 Sep 2021 | Classified by FDA | +22 days |
| 6 Oct 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
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 Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Where it was distributed
Nationwide domestic distribution. Foreign distribution worldwide.
Questions about this recall
Is Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) recalled?
Yes. Datascope recalled Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) on 8 Sep 2021. The recall is Class II and its status is Ongoing. Recall number Z-2616-2021.
Why was it recalled?
The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
Which lots are affected?
All lots
Where was it sold?
Nationwide domestic distribution. Foreign distribution worldwide.
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
All 134| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
Other Heart & Vascular Devices recalls
All 6,190| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |