FDA Device recall Z-0463-2016
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS by Boston Scientific, citing 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 doc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0463-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-20 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Number: M004EPM4790N40; Catalog number: EPM4790N4; 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
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.
Identifiers
| code_info | Material Number: M004EPM4790N40; Catalog number: EPM4790N4; Lot numbers: 16743398, 17135082.. Expiration Date Range: 2/16/2017 to 7/22/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0463-2016%22
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