CLASS II Device recall · Reported 8 Mar 2017 · FDA Enforcement Report
Cardiosave Hybrid Iabp and Cardiosave Rescue Iabp affected recalled
Maquet Datascope Corp - Cardiac Assist Division is recalling Cardiosave Hybrid Iabp and Cardiosave Rescue Iabp affected, distributed nationwide in the US. The recall was initiated on 23 Dec 2016 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-1386-2017
- FDA event ID
- 76052
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2016
- FDA classified
- 1 Mar 2017
- Reported
- 8 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 23 Dec 2016 | Recall initiated by company | |
| 1 Mar 2017 | Classified by FDA | +68 days |
| 8 Mar 2017 | 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
Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.
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 IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
Where it was distributed
Worldwide Distribution - US Nationwide
Questions about this recall
Why was it recalled?
Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.
Which lots are affected?
part number 0146-00-0097
Where was it sold?
Worldwide Distribution - US Nationwide
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 26 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 Maquet Datascope Corp - Cardiac Assist Division
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Cardiosave Rescue IABP recalled by Maquet Datascope Corp | Maquet Datascope Corp - Cardiac Assist Division | Other | Nationwide |
| Device | CLASS I | Cardiosave Hybrid IABP recalled by Maquet Datascope Corp | Maquet Datascope Corp - Cardiac Assist Division | Other | Nationwide |
| Device | CLASS I | Cardiosave Hybrid Intra-Aortic Balloon Pump (Iabp) recalled | Maquet Datascope Corp - Cardiac Assist Division | Other | 49 states |
| Device | CLASS I | CS 300 Intra-Aortic Balloon Pump recalled by Maquet Datascope Corp | Maquet Datascope Corp - Cardiac Assist Division | Device Malfunction | Nationwide |
| Device | CLASS I | CS 100i Intra-Aortic Balloon Pump recalled by Maquet Datascope Corp | Maquet Datascope Corp - Cardiac Assist Division | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |