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U.S. Department of Health and Human Services

Class 1 Device Recall Intella Tip MiFi Open Irrigated Ablation Catheter

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  Class 1 Device Recall Intella Tip MiFi Open Irrigated Ablation Catheter see related information
Date Initiated by Firm February 03, 2015
Date Posted March 02, 2015
Recall Status1 Terminated 3 on March 21, 2017
Recall Number Z-1209-2015
Recall Event ID 70506
Product Classification catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
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.
Code Information 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. 
Recalling Firm/
Manufacturer		 Boston Scientific Corp
150 Baytech Dr
San Jose CA 95134-2302
For Additional Information Contact Brent Hathcock
763-494-1133
Manufacturer Reason
for Recall		 Reports of formation of char adherent to the proximal part of the distal tip electrodes
FDA Determined
Cause 2		 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.
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.
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