Agency classClass IOur severity:Severe FDA (Devices)·Z-1763-2022·Announced 2022-10-05

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Category: Medical Device — Cardiac Support / Bypass Equipment
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.

Same manufacturer · Cardiac Assist, Inc

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Same hazard · software freeze