IntellaTip MiFi XP Asymmetric — Class II medical device recall Z-0462-2016
Terminated recall by Boston Scientific Corp, reported 2015-12-30, distributed nationwide. During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal ti
| Recall number | Z-0462-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corp, San Jose, CA, United States |
| Recall initiated | 2015-11-20 |
| Classified | 2015-12-22 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2019-11-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, DE, GB, GR, HK, IL, IR, IT, JP, KW, LV, MY, NL, SA, SG, TH, ZA |
| Quantity | 1,556 |
| Lot numbers | 16743760, 17135083, 17614450, 18140623, 18162387 |
| Model numbers | EPM4500N4 |
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.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.