FDAFDA · Food and drugs·Recall number Z-0701-2019
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
Published January 16, 2019 · Recall initiated: November 28, 2018
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Japan
- Lot
- IntellaNav Open-Irrigated Ablation Catheter Material Number: M004R96200 Batch: 22208397 Expiration Date: 6/4/2021 Batch: 22389516 Expiration Date: 7/16/2021 Batch: 22525798 Expiration Date: 2/14/2020
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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