FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular Us Sales, Llc: 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.
- Recall number
- Z-0589-2016
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- 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 hours or less.
- Status
- Terminated
- Initiated
- 2015-11-13
- Posted
- 2016-01-05
- Terminated
- 2017-04-07
- Reason
- 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.
- Root cause
- Device Design
- Action
- MAQUET sent "Product Recall Urgent Medical Device Field Correction" notices and "Medical Device Field Correction Response Forms" dated 11/13/2015 via UPS to affected customers. The notification identified the issue and how to identify the affected unit. The notification instructed customers to always keep a replacement heater-cooler unit on standby in the event of a unit failure; complete the attached Field Correction Response form (fax to 1.973.629.1518 or email to HCU30@maquet.com; and that they would be contacted by a representative of the Maquet Service Team to schedule an onsite service to determine if the power supply board in their HCU 30 Type 2 unit is affected adn replace the power supply board as necessary. If the customer had any questions they are instructed to contact their Maquet Service Representative or Maquet Technical Support at 1.888.627.8383 (Press option 3, followed by Option 1 and then option 1 again), Monday through Friday between the hours of 8:00 am and 5:00 pm.
- Quantity
- 100 Units (distributed in United States)
- Distribution
- United States Nationwide Distribution
- Lot, serial or model codes
- 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, Model Number 705501/70103.4653 Heater Cooler Unit 30 with Serial Number <93101480 The affected power supply boards have serial numbers less than 107006001.
- 510(k) numbers
- ["K031544"]
- PMA numbers
- not on file
- Product code
- DWC
- Firm FEI
- 3008355164
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28