TandemLife LifeSPARC 5840-2415Recalls & reported problems
Cardiacassist, Inc. · LifeSPARC Blood Pump, TandemLung Oxygenator, 15 Fr Arterial Cannula, 24 Fr Venous Cannnula and accessories · Class 1
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 19, 2021Terminated
On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field.
Z-1486-2021 · Root cause: Under Investigation by firm · FDA record ↗
Other Accessory Equipment, Cardiopulmonary Bypass devices
- LifeSPARC 5800-1000Cardiacassist, Inc. · Accessory Equipment, Cardiopulmonary Bypass1 recall1 death9 reports
- NA INFUSION POLEMaquet Cardiopulmonary AG · ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS1 recall0 reports
- NA Conv.kitMaquet Cardiopulmonary AG · ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS1 recall0 reports
- LifeSPARC 5800-0000Cardiacassist, Inc. · Accessory Equipment, Cardiopulmonary Bypass2 reports
- CentriMag™ 201-50112Thoratec Corporation · ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.