Boston Scientific Recalls IntellaTip MiFi Radiofrequency Ablation Catheters

Plain-English summary

Boston Scientific Corp is recalling 14 units of IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters. The affected devices include specific material and catalog numbers (M004EPM96200/EPM9620, M004EPM9620K20/EPM9620K2, and M004EPM9620N40/EPM9620N4) with expiry dates ranging from April 20, 2015, to June 14, 2015.

The recall was initiated due to reports of char formation adherent to the proximal part of the distal tip electrodes. The product is a 7.5F quadrapolar open-irrigated ablation catheter designed to deliver radiofrequency energy for cardiac ablation. The source text notes that the product is not approved for use or sale in the US.

The devices were distributed in Germany, Great Britain, and the Netherlands. Specific serial numbers for the affected units are listed in the recall documentation. Users should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

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-Ir

Manufacturer

Boston Scientific Corp

Category

Medical Device — Cardiac Ablation Catheter

Hazard

• char-formation

Affected units

14

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distribution scope not specified by the agency.

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