IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation cathe...
FDA Recall #Z-0700-2019 — Class III — November 28, 2018
Product Description
IntellaTip 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
Reason for Recall
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.
Recalling Firm
Boston Scientific Corporation — Marlborough, MA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
1,282 (all three types in Japan)
Distribution
Japan
Code Information
IntellaTip MiFi Open-Irrigated Ablation Catheter Material Number: M004PM96200 Batch: 20368736 Expiration Date: 3/5/2020 Batch: 20531648 Expiration Date: 4/16/2020 Batch: 20560477 Expiration Date: 4/23/2020 Batch: 20566637 Expiration Date: 4/24/2020 Batch: 20628704 Expiration Date: 5/9/2020 Batch: 20628705 Expiration Date: 5/10/2020 Batch: 20763900 Expiration Date: 6/12/2020 Batch: 20769113 Expiration Date: 6/13/2020 Batch: 21318000 Expiration Date: 10/29/2020 Batch: 21318001 Expiration Date: 10/29/2020 Batch: 21357647 Expiration Date: 11/10/2020 Batch: 21463186 Expiration Date: 12/3/2020 Batch: 21543193 Expiration Date: 12/20/2020 Batch: 21574774 Expiration Date: 1/4/2021 Batch: 22195929 Expiration Date: 5/31/2021 Batch: 22202991 Expiration Date: 6/3/2021 Batch: 22290601 Expiration Date: 6/3/2021 Batch: 22305067 Expiration Date: 6/25/2021 Batch: 22315782 Expiration Date: 6/27/2021 Batch: 22317356 Expiration Date: 6/28/2021 Batch: 22327178 Expiration Date: 7/1/2021 Batch: 22329367 Expiration Date: 7/2/2021 Batch: 22330626 Expiration Date: 7/2/2021 Batch: 22371866 Expiration Date: 7/12/2021 Batch: 22371868 Expiration Date: 7/12/2021 Batch: 22379905 Expiration Date: 7/15/2021 Batch: 22435929 Expiration Date: 7/26/2021 Batch: 22435930 Expiration Date: 7/26/2021 Batch: 22438118 Expiration Date: 7/27/2021 Batch: 22455198 Expiration Date: 7/31/2021 Batch: 22499957 Expiration Date: 8/10/2021 Material Number: M004PM9620K20 Batch: 20371559 Expiration Date: 3/6/2020 Batch: 20542305 Expiration Date: 4/18/2020 Batch: 20548241 Expiration Date: 4/19/2020 Batch: 20639975 Expiration Date: 5/14/2020 Batch: 20677314 Expiration Date: 5/21/2020 Batch: 20772834 Expiration Date: 6/14/2020 Batch: 22321772 Expiration Date: 6/29/2021 Batch: 22326857 Expiration Date: 7/1/2021 Material Number: M004PM9620N40 Batch: 20371742 Expiration Date: 3/8/2020 Batch: 20463744 Expiration Date: 3/28/2020 Batch: 20622763 Expiration Date: 5/8/2020 Batch: 20775597 Expiration Date: 6/14/2020 Batch: 22340824 Expiration Date: 7/4/2021 Batch: 22371871 Expiration Date: 7/12/2021 Batch: 22374909 Expiration Date: 7/13/2021
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.