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Terminated

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.

FDA Recall Z-1209-2015 · Posted 2015-03-02

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeOAD
Date Initiated2015-02-03
Date Terminated2017-03-21
Product Quantity14 units

Reason for Recall

Reports of formation of char adherent to the proximal part of the distal tip electrodes

Firm Action

Customer notification letters were sent by overnight mail on February 10, 2015.

Root Cause

Device Design

Distribution Pattern

Distributed in Germany, Great Britain, and the Netherlands.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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