Z-1209-2015Class I

IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog...

Name: Z-1209-2015 IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog...
Creator: Boston Scientific Corp
Published: 2015-02-03
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2015-02-03 / Terminated / root cause: design

FDA source

Boston Scientific Corp began a recall of IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20... on 2015-02-03. FDA classified it as Class I and gives the reason as "Reports of formation of char adherent to the proximal part of the distal tip electrodes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1209-2015
Classification: Class I
Status: Terminated
Initiated: 2015-02-03
Posted: 2015-03-02
Terminated: 2017-03-21
Recalling firm: Boston Scientific Corporation
Product: IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation The product is not approved for use/sale in the US.
Product code: OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Reason for recall: Reports of formation of char adherent to the proximal part of the distal tip electrodes
Root cause tag: design
FDA root cause: Device Design
Action: Customer notification letters were sent by overnight mail on February 10, 2015.
Quantity in commerce: 14 units
Distribution: Distributed in Germany, Great Britain, and the Netherlands.
Product codes and lots: Material number: M004EPM96200, Catalog Number EPM9620; Serial numbers: 16941576, 16943730, 17150129, 17156568, 17156570, 17168752, 17171230, 17218387, 17221754, 17237747, 17247469, 17261879. Material number: M004EPM9620K20, Catalog Number: EPM9620K2: Serial numbers : 17018928, 17018929, 17147617, 17172602, 17175351, 17223957, 17230227, 17233882, 17235011, 17241926, 17263604, 17285884, 17288714. Material number : M004EPM9620N40; Catalog number: EPM9620N4; Serial numbers: 17148152, 17226126, 17266642. All with Expiry Dates of April 20, 2015 - June 14, 2015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1209-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1209-2015	Class I	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-02

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)