Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported March 4, 2020
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
Perfusion tubing pack was packaged with the incorrect cuvette.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
LivaNova USA Inc. recalled LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfu… - a low-severity action.
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfu… was recalled by LivaNova USA Inc. in March 4, 2020. Reason: Perfusion tubing pack was packaged with the incorrect cuvette.. Check the official notice for the remedy. Verify recall #Z-1389-2020 with the FDA Devices before acting.
The recall
LivaNova USA Inc. issued this low-severity FDA Devices recall-Perfusion tubing pack was packaged with the incorrect cuvette..
- Low
- severity level
- Class III
- classification
- March 4, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1389-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1389-2020) was formally reported on March 4, 2020, with the manufacturer initiating the action on July 3, 2019. It is classified under Low severity (Class III), 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 27 packs.
The documented reason for this recall is: Perfusion tubing pack was packaged with the incorrect cuvette. Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of IL.. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
27 packs
Related Recalls
6
3 from same agency
Product description
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
Reason for recall
Perfusion tubing pack was packaged with the incorrect cuvette.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1389-2020 |
| Date reported | March 4, 2020 |
| Date initiated | July 3, 2019 |
| Recalling firm | LivaNova USA Inc. |
| Firm location | Arvada, CO |
| Affected scope | 27 packs |
| Distribution | US Nationwide distribution in the state of IL. |
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-1389-2020) 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 SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.. Recalled by LivaNova USA Inc.. Units affected: 27 packs.
Why was this product recalled? ▼
Perfusion tubing pack was packaged with the incorrect cuvette.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 4, 2020. Severity: Low. Recall number: Z-1389-2020.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the state of IL..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1389-2020) 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.
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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 4, 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.