IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters:… — Class I medical device recall Z-1209-2015
Terminated recall by Boston Scientific Corp, reported 2015-03-11. Reports of formation of char adherent to the proximal part of the distal tip electrodes
| Recall number | Z-1209-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corp, San Jose, CA, United States |
| Recall initiated | 2015-02-03 |
| Classified | 2015-03-02 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2017-03-21 |
| Countries outside the US | DE, GB, NL |
| Quantity | 14 units |
| Serial numbers | 16941576, 16943730, 17018928, 17018929, 17147617, 17148152, 17150129, 17156568, 17156570, 17168752, 17171230, 17172602, 17175351, 17218387, 17221754, 17223957, 17226126, 17230227, 17233882, 17235011, 17237747, 17241926, 17247469, 17261879, 17263604 and 3 more |
| Model numbers | EPM9620, EPM9620K2, EPM9620N4 |
Product
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation The product is not approved for use/sale in the US.
Reason for recall
Reports of formation of char adherent to the proximal part of the distal tip electrodes
Machine access
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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.