Boston Scientific Corporation recalls IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a com…

Recall date

November 28, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0701-2019

FDA classification

Class III

Brand / firm

Boston Scientific Corporation

Sold / distributed

Japan

Why it was recalled

Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system