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.
This recall has been terminated (originally issued November 20, 2015).
- Company
- Boston Scientific Corp
- Recall Initiated
- November 20, 2015
- Terminated
- November 27, 2019
- Recall Number
- Z-0464-2016
- Quantity
- 1556 total - all models
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
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.