Safire Duo Ablation Catheter MediGuide Enabled — Class II medical device recall Z-0187-2014
Terminated recall by St. Jude Medical, reported 2013-11-20, distributed nationwide. St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification rega
| Recall number | Z-0187-2014 |
|---|---|
| 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 | 2013-11-08 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2014-06-09 |
| Distributed | Nationwide (US) |
| Quantity | 46 |
| Lot numbers | 4113242, 4113243, 4124985, 4152911 |
| Model numbers | A700238, A700240 |
Product
Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
Reason for recall
St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended.
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-0187-2014. 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.