US Safire Duo Ablation Catheter MediGuide Enabled — Class II medical device recall Z-0174-2014
Terminated recall by St. Jude Medical, reported 2013-11-13, distributed in KS, KY, MA, OH, TX, UT. St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification rega
| Recall number | Z-0174-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Plymouth, MN, United States |
| Recall initiated | 2013-10-11 |
| Classified | 2013-11-06 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2016-03-10 |
| Distributed | KS, KY, MA, OH, TX, UT |
| Quantity | 59 |
| Lot numbers | 4113241, 4113242 |
| Model numbers | A700240, A700244 |
Product
US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation catheters are used with the MediGuide Technology to enable real-time tip positioning and navigation and in conjunction the the EnSite Velocity System. The MediGuide Technology is indicated for use as an adjunct to fluoroscopy.
Reason for recall
St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and Safire Duo Ablation Catheter MediGuide Enabled. These units were inadvertently shipped with the incorrect version of the Instructions for Use (IFU).
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-0174-2014. 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.