FDA Device recall Z-1209-2015
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number:…
- FDA Device
- Class I
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class I recall of IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number:… by Boston Scientific, citing reports of formation of char adherent to the proximal part of the distal tip electrodes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1209-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-02-03 |
| Published | 2015-03-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
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
Reports of formation of char adherent to the proximal part of the distal tip electrodes
Identifiers
| code_info | Material number: M004EPM96200, Catalog Number EPM9620; Serial numbers: 16941576, 16943730, 17150129, 17156568, 1715657…Material number: M004EPM96200, Catalog Number EPM9620; Serial numbers: 16941576, 16943730, 17150129, 17156568, 17156570, 17168752, 17171230, 17218387, 17221754, 17237747, 17247469, 17261879. Material number: M004EPM9620K20, Catalog Number: EPM9620K2: Serial numbers : 17018928, 17018929, 17147617, 17172602, 17175351, 17223957, 17230227, 17233882, 17235011, 17241926, 17263604, 17285884, 17288714. Material number : M004EPM9620N40; Catalog number: EPM9620N4; Serial numbers: 17148152, 17226126, 17266642. All with Expiry Dates of April 20, 2015 - June 14, 2015. |
|---|
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-1209-2015%22
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