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U.S. Department of Health and Human Services

Class 2 Device Recall IntelliTip MiFi XP Asymmetric Curve Temperature Ablation Catheter

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  Class 2 Device Recall IntelliTip MiFi XP Asymmetric Curve Temperature Ablation Catheter see related information
Date Initiated by Firm November 20, 2015
Create Date December 22, 2015
Recall Status1 Terminated 3 on November 27, 2019
Recall Number Z-0464-2016
Recall Event ID 72721
PMA Number P020025S036 
Product Classification catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
Product IntellaTip MiFi XP Asymmetric (N4) Curve
7/110/2.5/8-8
Material Number: M004PM4500N40; Catalog number: PM4500N4;

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.
Code Information Material Number: M004PM4500N40;  Catalog number: PM4500N4; Lot numbers: 16309584, 16615976, 16623754, 16623755, 16722434, 16736927, 16739588, 16743271, 16872124, 16999075, 17118111, 17157418, 17201805, 17222051, 17222052, 17370483, 17376573, 17376574, 17436562, 17436563, 17436565, 17451802, 17478950, 17499145, 17499152, 17590503, 17611785, 17625992, 17768306, 17791420, 17925492, 17925493, 18012208, 18161715. Expiration Date Range:8/15/2016 to 7/2/2018. 
Recalling Firm/
Manufacturer		 Boston Scientific Corp
150 Baytech Dr
San Jose CA 95134-2302
For Additional Information Contact Nicole Pshon
763-494-7971
Manufacturer 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 BSCs product risk documentation.
FDA Determined
Cause 2		 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 total - 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = OAD and Original Applicant = BOSTON SCIENTIFIC
PMAs with Product Code = OAD and Original Applicant = Boston Scientific Corp.
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