MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia… — Class II medical device recall Z-1165-2014
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2014-03-19, distributed nationwide. The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia tempera
| Recall number | Z-1165-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2014-01-31 |
| Classified | 2014-03-10 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2015-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, DE, TR |
| Quantity | 1,424 units |
| Lot numbers | 15200, 70105.0647 |
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 during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.
Reason for recall
The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardioplegia Heat Exchanger (PLEGIOX) is used in conjunction with a heater/cooler unit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1165-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.