Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 25, 2020
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
LivaNova USA Inc. recalled LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to … - a moderate-severity action.
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to … was recalled by LivaNova USA Inc. in March 25, 2020. Reason: The firm is providing validated cleaning and disinfection instructions in their revised operating instruction…. Check the official notice for the remedy. Verify recall #Z-1498-2020 with the FDA Devices before acting.
The recall
LivaNova USA Inc. issued this moderate-severity FDA Devices recall-The firm is providing validated cleaning and disinfection instructions in their revised operating instruction….
- Moderate
- severity level
- Class II
- classification
- March 25, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1498-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1498-2020) was formally reported on March 25, 2020, with the manufacturer initiating the action on February 24, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. LivaNova USA Inc. is listed as the recalling firm, operating out of Arvada, CO. Federal records list the affected scope as Total Worldwide=9309 systems (2713 system in U.S.).
The documented reason for this recall is: The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination. Distribution data in the federal record shows the product reached: U.S. Nationwide distribution including Puerto Rico. This matter was triggered by the clearance of K191402, thus only the United States, including Puerto Rico, is affected. O.U.S. - none. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Total Worldwide=9309 systems (2713 system in U.S.)
Related Recalls
6
3 from same agency
Product description
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
Reason for recall
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1498-2020 |
| Date reported | March 25, 2020 |
| Date initiated | February 24, 2020 |
| Recalling firm | LivaNova USA Inc. |
| Firm location | Arvada, CO |
| Affected scope | Total Worldwide=9309 systems (2713 system in U.S.) |
| Distribution | U.S. Nationwide distribution including Puerto Rico. This matter was triggered by the clearance of K191402, thus only the United States, including Puerto Rico, is affected. O.U.S. - none |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1498-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.. Recalled by LivaNova USA Inc.. Units affected: Total Worldwide=9309 systems (2713 system in U.S.).
Why was this product recalled? ▼
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2020. Severity: Moderate. Recall number: Z-1498-2020.
Where was the recalled product distributed? ▼
Distribution: U.S. Nationwide distribution including Puerto Rico. This matter was triggered by the clearance of K191402, thus only the United States, including Puerto Rico, is affected. O.U.S. - none.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1498-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 25, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.