TANDEM LIFE LIFESPARC Controller Recall: Critical Software Failure Risk
TANDEM LIFE recalls LIFESPARC Controller models 5900-0000 and 5900-0001 due to critical software freezing that may cause data loss. Affected units have specific serial numbers listed in the recall notice.
Use caution until it’s fixed
Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
Contact the company
What happened, in plain English
TANDEM LIFE is recalling two specific models of LIFESPARC controllers (5900-0000 and 5900-0001) because their software can freeze or crash, leading to the screen not displaying data. This could disrupt critical medical monitoring for patients using circulatory or cardiopulmonary bypass systems. Read more at govinfonow.com/recall/60329-tandem-life-lifesparc-controller-recall-critical-software-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/60329-tandem-life-lifesparc-controller-recall-critical-software-failure-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1763-2022
Cite this page
“TANDEM LIFE LIFESPARC Controller Recall: Critical Software Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60329-tandem-life-lifesparc-controller-recall-critical-software-failure-risk. Based on FDA recall #Z-1763-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1763-2022%22&limit=1).
Why it’s dangerous
The controller's software can freeze or crash, causing the screen to stop displaying data. This could lead to loss of critical monitoring information for patients undergoing circulatory or cardiopulmonary bypass procedures, potentially affecting treatment safety.
Who’s affected
Patients using circulatory or cardiopulmonary bypass systems with the specific controller models and serial numbers listed in the recall notice are most at risk. Medical professionals who use these controllers in hospital settings may also be affected.
How to tell if you have this one
Check for the model numbers 5900-0000 (with UDI-DI: 00814112020562) or 5900-0001 (with UDI-DI: 00814112020623) on the device. Affected units have specific serial numbers listed in the recall notice.
- Brand
TANDEM LIFE- Category
Medical device
What to do — step by step
Check Controller Model
Identify if your controller is model 5900-0000 or 5900-0001 with the specified UDI-DI numbers.
Verify Serial Number
Confirm your controller's serial number is in the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1763-2022 (July 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1763-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.