Z-0462-2016Class II

IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number...

Name: Z-0462-2016 IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number...
Creator: Boston Scientific Corp
Published: 2015-11-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2015-11-20 / Terminated / root cause: design

FDA source

Boston Scientific Corp began a recall of IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: The IntellaTip MiFi XP... on 2015-11-20. FDA classified it as Class II and gives the reason as "During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSC's product risk documentation". 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-0462-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-20
Posted: 2015-12-22
Terminated: 2019-11-27
Recalling firm: Boston Scientific Corporation
Product: IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia typically chronic, drug refractory atrial fibrillation.
Product code: OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Reason for recall: During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSC's product risk documentation.
Root cause tag: design
FDA root cause: Device Design
Action: Boston Scientific sent an Urgent Medical Device Removal letters to all affected customers dated November 20, 2015 via Fed Ex or other equivalent service. The letter identified the affected products, problem and actions to be taken. Customers were instructed to contact their local Sales Representative to answer any questions.
Quantity in commerce: 1556 - all models
Distribution: Worldwide Distribution - US Nationwide in the state of: PA, FL, IN, MI, TN, AL, IL, KY, MI, TX, OH, MO, MA, MN, ID, AL, TN, VA, CA and internationally to Austria, Australia, Belgium, Switzerland, Germany, Great Britain, Greece, Hong Kong, Israel, Iran, Italy, Japan, Kuwait, Latvia, Malaysia, Netherlands, Saudi Arabia, Singapore, Thailand, and South Africa.
Product codes and lots: Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Lot numbers: 16743760, 17135083, 17614450, 18140623, 18162387. Expiration Date Range: 2/16/2017 to 7/3/2018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0462-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0462-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-22
Z-0463-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-22
Z-0464-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-22
Z-0465-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-22

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)