IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation cathe...
FDA Device Recall #Z-0700-2019 — Class III — November 28, 2018
Recall Summary
| Recall Number | Z-0700-2019 |
| Classification | Class III — Low risk |
| Date Initiated | November 28, 2018 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Boston Scientific Corporation |
| Location | Marlborough, MA |
| Product Type | Devices |
| Quantity | 1,282 (all three types in Japan) |
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.
Distribution Pattern
Japan
Lot / 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
Other Recalls from Boston Scientific Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2049-2026 | Class II | LUX-Dx II Plus, Arrythmia detector and alarm, M... | Mar 30, 2026 |
| Z-2048-2026 | Class II | LUX-DX II, Arrythmia detector and alarm, Model ... | Mar 30, 2026 |
| Z-1770-2026 | Class I | Boston Scientific Pacemaker, Implantable Pulse ... | Mar 19, 2026 |
| Z-1771-2026 | Class I | Boston Scientific Cardiac Resynchronization The... | Mar 19, 2026 |
| Z-1551-2026 | Class II | EndoVive Safety PEG Kit; Outer Box Material Nu... | Feb 10, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.