CLASS I ONGOING Device recall · Reported 7 Nov 2018 · FDA Enforcement Report
Cardiosave Rescue IABP recalled by Maquet Datascope Corp
Maquet Datascope Corp - Cardiac Assist Division is recalling Cardiosave Rescue IABP, distributed nationwide in the US. The recall was initiated on 20 Sep 2018 and the FDA has classified it as Class I.
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-0100-2019
- FDA event ID
- 81055
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division, Mahwah, NJ
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 20 Sep 2018
- FDA classified
- 26 Oct 2018
- Reported
- 7 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Sep 2018 | Recall initiated by company | |
| 26 Oct 2018 | Classified by FDA | +36 days |
| 7 Nov 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
Where it was distributed
US Nationwide; Internationally to 77 countries
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI - 10607567108407 All Serial Numbers
Where was it sold?
US Nationwide; Internationally to 77 countries
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
Other products in this recall event
1 other product · FDA event 81055This product is part of a recall event; the main page for the event is Cardiosave Hybrid IABP recalled by Maquet Datascope Corp.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Cardiosave Hybrid IABP recalled by Maquet Datascope Corp | Maquet Datascope Corp - Cardiac Assist Division | Other | Nationwide |
More recalls from Maquet Datascope Corp - Cardiac Assist Division
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS I | CS 100 Intra-Aortic Balloon Pump recalled by Maquet Datascope Corp | Maquet Datascope Corp - Cardiac Assist Division | Device Malfunction | Nationwide |
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