LifeSPARC Cardiac Pump Recalled Due to Uncured Epoxy Manufacturing Defect
Cardiac Assist, Inc. is recalling the LifeSPARC Pump due to uncured epoxy used during manufacturing that may cause early device failure. Two units were distributed in Illinois and Florida.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for a life-critical cardiac assist pump with potential device failure due to manufacturing defect. No illnesses or injuries have been reported, placing this in the high-risk category where the hazard is unreported but the product's critical nature makes the failure risk serious.
Plain-English summary
Cardiac Assist, Inc. is recalling the LifeSPARC Pump (part number 5800-0000), which is contained within the TandemLife LifeSPARC Priming Tray (part number 5800-1000). The recalled component may also be found in TandemLife Kits 5830-2916 and 5840-2417. Two units have been identified with this defect.
The epoxy used during manufacturing of the LifeSPARC Pump may not have fully cured. If the epoxy remains uncured, it may result in early pump failure, potentially compromising the device's ability to function as intended.
According to FDA records, the affected units were distributed nationwide to locations in Illinois and Florida. The specific serial numbers are: Kit 5830-2916 (Pump SN 00876971) and Kit 5840-2417 (Pump SN 00876972).
Patients or healthcare providers who have received this device should contact Cardiac Assist, Inc. immediately for guidance. Do not use the device until receiving instructions from the manufacturer or your healthcare provider.
The recalled product
- Product
- LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TAND
- Manufacturer
- Cardiac Assist, Inc
- Hazard
- device-failure
- manufacturing-defect
Distribution
Distributed nationwide across the United States.
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