FDA Devices recall · Reported December 28, 2016
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion¿ Oxygenators with Balance¿1 Biosurface. These are distributed as stand-alone dev…
Medtronic Inc recalled Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/… - a moderate-severity action.
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/… was recalled by Medtronic Inc in December 28, 2016. Reason: Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion¿ Oxygenato…. Check the official notice for the remedy. Verify recall #Z-0826-2017 with the FDA Devices before acting.
The recall
Medtronic Inc issued this moderate-severity FDA Devices recall-Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion¿ Oxygenato….
- Moderate
- severity level
- Class II
- classification
- December 28, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0826-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
Reason for recall
Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion¿ Oxygenators with Balance¿1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0826-2017 |
| Date reported | December 28, 2016 |
| Date initiated | November 16, 2016 |
| Recalling firm | Medtronic Inc |
| Firm location | Minneapolis, MN |
| Affected scope | 5609 (663 US; 4946 OUS) |
| Distribution | Worldwide Distribution-US (nationwide) in states of: AK, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, LA, MN, ND, NV, NY, SD, TN, TX, WI, WY and countries of: Canada, Chile, Croatia, Germany, Greece, Hungary, Iran, Italy, Latvia, Lebanon, Pol… |
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-0826-2017) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026