TANDEM LIFE controller software failures affecting cardiopulmonary bypass equipment nationwide
FDA recalls TANDEM LIFE LivaNova LIFESPARC Controllers due to critical software failures that cause the device to freeze, crash, or stop displaying data. The controllers are used in cardiopulmonary bypass procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is a Class I FDA recall, which requires a minimum severity score of 4 per the rubric. While no injuries or deaths have been reported, the critical software failures affecting life-critical bypass equipment meet the Severe classification threshold.
Plain-English summary
The TANDEM LIFE LivaNova LIFESPARC Controller is being recalled due to critical software failures. The device is used for circulatory and cardiopulmonary bypass support.
The controller's software may freeze or crash, causing the display screen to stop showing data. These are critical failures that directly affect device operation.
A total of 723 units of the affected controller were distributed nationwide, with 484 units currently in field. The recall applies to Model 5900-0000 (Controller and Accessories) and Model 5900-0001 (Controller Only), manufactured by Cardiac Assist, Inc.
The FDA has issued a Class I recall classification for this device due to the critical nature of the software failures and the device's use in life-critical cardiopulmonary applications.
The recalled product
- Product
- TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
- Manufacturer
- Cardiac Assist, Inc
- Hazard
- software-freeze
- software-crash
- display-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- C50232
- C50253
- C50403
- C00195
- C50619
- C50623
- C50161
- C50167
- C50388
- C50432
- C50505
- C00189
- C50437
- C50671
- C50690
- C50362
- C50648
- C00048
- C00087
- C00149
Distribution
Distributed nationwide across the United States.
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