FDA Device recall Z-0701-2019
IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequen…
- FDA Device
- Class III
- ongoing
- Published 2019-01-16
On 2019-01-16 the FDA classified a Class III recall of IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequen… by Boston Scientific, citing 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 refle….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0701-2019 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2018-11-28 |
| Published | 2019-01-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
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
Reason
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.
Identifiers
| code_info | IntellaNav Open-Irrigated Ablation Catheter Material Number: M004R96200 Batch: 22208397 Expiration Date: 6/4/2021 Ba…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0701-2019%22
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