CLASS II Device recall · Reported 30 Dec 2015 · FDA Enforcement Report
IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS recalled
Boston Scientific is recalling IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS, distributed nationwide in the US. The recall was initiated on 20 Nov 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0462-2016
- FDA event ID
- 72721
- Recalling firm
- Boston Scientific, San Jose, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Nov 2015
- FDA classified
- 22 Dec 2015
- Reported
- 30 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 20 Nov 2015 | Recall initiated by company | |
| 22 Dec 2015 | Classified by FDA | +32 days |
| 30 Dec 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaCaliforniaFloridaIdahoIllinoisIndianaKentuckyMassachusettsMichiganMinnesotaMissouriOhioPennsylvaniaTennesseeTexasVirginia
Questions about this recall
Why was it 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.
Which lots are affected?
Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Lot numbers: 16743760, 17135083, 17614450, 18140623, 18162387. Expiration Date Range: 2/16/2017 to 7/3/2018.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 72721This product is part of a recall event; the main page for the event is IntellaTip MiFi XP Asymmetric recalled by Boston Scientific.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | IntellaTip MiFi XP Asymmetric recalled by Boston Scientific | Boston Scientific | Other | Nationwide | |
| CLASS II | IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8 recalled | Boston Scientific | Other | Nationwide | |
| CLASS II | IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS recalled | Boston Scientific | Other | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS I | Enroute Transcarotid Neuroprotection System recalled | Boston Scientific | Other | Nationwide |
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Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |