Maquet Plegiox Cardioplegia Heat Exchanger Recalled for Temperature Discrepancy
Maquet is recalling 1,424 Plegiox Cardioplegia Heat Exchangers because they may fail to reach the desired cardioplegia temperature when used with a heater/cooler unit.
What this means for you
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 medical device failing to maintain required temperatures during cardiac surgery, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 1,424 units of the Plegiox Cardioplegia Heat Exchanger. The product is used as part of a cardioplegia system to set and maintain temperature for blood and crystalloid cardioplegic solutions during extracorporeal circulation. The units were distributed nationwide in the United States, as well as in Brazil, Germany, and Turkey.
The recall was initiated after Maquet's post-marketing vigilance program identified a discrepancy where the desired cardioplegia temperature may not be obtained when the Plegiox is used in conjunction with a heater/cooler unit. The product is designed for single use only, with an application period of no longer than 6 hours.
Healthcare facilities and distributors should stop using the affected units and contact Maquet Cardiovascular US Sales, LLC for instructions on return or replacement. The recall covers specific order numbers, model numbers, and lot numbers listed in the official FDA recall notice Z-1165-2014.
The recalled product
- Product
- MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Affected units
- 1,424
Distribution
Distributed nationwide across the United States.
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