Z-0701-2019Class III

IntellaNav MiFi Open-Irrigated Ablation Catheter

Name: Z-0701-2019 IntellaNav MiFi Open-Irrigated Ablation Catheter
Creator: Boston Scientific Corporation
Published: 2018-11-28
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2018-11-28 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller... on 2018-11-28. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0701-2019
Classification: Class III
Status: Open, Classified
Initiated: 2018-11-28
Posted: 2019-01-08
Recalling firm: Boston Scientific Corporation
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
Product code: OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On November 28, 2018, Boston Scientific sent Urgent Medical Device Removal - Immediate Action Required letters to their Japanese consignees requesting them to check and segregate any of the recalled product. The letter also asked the consignees to conduct sub-recalls, if necessary, and to return The Reply Verification Tracking Form.
Quantity in commerce: 1,282 (all three types in Japan)
Distribution: Japan
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0701-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0699-2019	Class III	Ongoing	Voluntary: Firm initiated	2019-01-16	2019-01-08
Z-0700-2019	Class III	Ongoing	Voluntary: Firm initiated	2019-01-16	2019-01-08
Z-0701-2019	Class III	Ongoing	Voluntary: Firm initiated	2019-01-16	2019-01-08

Product code OAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)