The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0589-2016·Announced 2016-01-13

Maquet HCU 30 Heater-Cooler Unit Recalled for Power Supply Board Failure

Maquet is recalling HCU 30 Heater-Cooler Units due to a power supply board defect that can cause overheating and unit shutdown during cardiopulmonary bypass procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device failure during surgery) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling the HCU 30 Heater-Cooler Unit (HCU) Type 2. This medical device is intended to circulate water through heat exchange circuits to warm or cool a patient during short-duration cardiopulmonary bypass procedures lasting six hours or less. The recall involves 100 units distributed nationwide in the United States.

The recall is due to a failure of the Type 2 power supply board. A voltage drop of more than 10% can cause the R56 thermistor on the power supply board to overheat and fail. This failure typically occurs when the compressor is switched on prior to patient use, but it can also occur during patient use. The failure can result in the shutdown of the compressor or the entire HCU 30 Type 2 unit.

Affected units include the HCU 30 Base Unit 100 (120 V), HCU 30 Base Unit 200 (240 V), and HCU 30 Base Unit Canadian/US. Specifically, the recall covers units with serial numbers less than 93101480 and power supply boards with serial numbers less than 107006001. Healthcare facilities should contact Maquet Cardiovascular US Sales, LLC for instructions on how to proceed with the recall.

The recalled product

Product
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…
Manufacturer
Maquet Cardiovascular Us Sales, Llc
Category
Medical Device — Cardiopulmonary Bypass Equipment
Hazard
Affected units
100

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • HCU 30 Base Unit 100 - 120 V
  • Model Number 704629/70103.4371 HCU 30 Base Unit 200 - 240 V
  • Model Number 704631/70103.4642 HCU 30 Base Unit Canadian/US

Distribution

Distributed nationwide across the United States.

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