Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 Recalled by Boston Scientific Corp Due to During routine monitoring of complaints, BSC noted that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corp directly.
Affected Products
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; 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.
Quantity: 1556 total - all models
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Boston Scientific Corp
Boston Scientific Corp has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report