Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model… — Class II medical device recall Z-2196-2012
Terminated recall by Edwards Lifesciences, LLC, reported 2012-08-22, distributed nationwide. The device is being recalled because the firm received multiple complaints related to passage of a J-tip guide
| Recall number | Z-2196-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2012-05-11 |
| Classified | 2012-08-12 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2014-06-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, CO, HK, HN, ID, JP, MX, MY, PA, TH, TW |
| Quantity | 32,145 units |
| Model numbers | 151F7 |
Product
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.
Reason for recall
The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
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-2196-2012. 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.