Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number… — Class II medical device recall Z-1700-2015
Terminated recall by Edwards Lifesciences, LLC, reported 2015-06-10, distributed nationwide. The product failed to meet the internal established statistical test requirement for heparin activity.
| Recall number | Z-1700-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2015-05-05 |
| Classified | 2015-06-02 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2016-10-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 978 |
| Lot numbers | 59860969 |
| Model numbers | 744HF75 |
Product
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.
Reason for recall
The product failed to meet the internal established statistical test requirement for heparin activity.
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-1700-2015. 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.