FDA Devices recall · Reported January 13, 2016
Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cause overheating and subsequent failing of the R56 thermistor of the pow…
Maquet Cardiovascular Us Sales, Llc recalled Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Us… - a moderate-severity action.
Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Us… was recalled by Maquet Cardiovascular Us Sales, Llc in January 13, 2016. Reason: Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cau…. Check the official notice for the remedy. Verify recall #Z-0589-2016 with the FDA Devices before acting.
The recall
Maquet Cardiovascular Us Sales, Llc issued this moderate-severity FDA Devices recall-Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cau….
- Moderate
- severity level
- 100 units
- affected scope
- Class II
- classification
- January 13, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0589-2016 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
Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
Reason for recall
Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cause overheating and subsequent failing of the R56 thermistor of the power supply board. Board failure typically occurs when the compressor is switched on (prior to patient use); however, it can occur during patient use. This can shut down the compressor or the entire HCU 30 Type 2 unit.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0589-2016 |
| Date reported | January 13, 2016 |
| Date initiated | November 13, 2015 |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Firm location | Wayne, NJ |
| Affected scope | 100 Units (distributed in United States) |
| Distribution | United States Nationwide Distribution |
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-0589-2016) 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