FDA Device recall Z-1700-2015
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75
- FDA Device
- Class II
- terminated
- Published 2015-06-10
On 2015-06-10 the FDA classified a Class II recall of Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75 by Edwards Lifesciences, citing the product failed to meet the internal established statistical test requirement for heparin activity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1700-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-05 |
| Published | 2015-06-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
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
The product failed to meet the internal established statistical test requirement for heparin activity.
Identifiers
| code_info | lot number 59860969. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1700-2015%22
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