The Recall Desk
ModerateFDA (Devices)·Z-0462-2016·Announced 2015-12-30

Boston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends

Boston Scientific is recalling IntellaTip MiFi XP catheters because the rate of distal tip bends and kinks exceeded anticipated levels during routine monitoring.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Boston Scientific Corp is recalling 1,556 units of the IntellaTip MiFi XP Asymmetric (N4) Curve catheter. The recall involves specific material and catalog numbers, with lot numbers ranging from 16743760 to 18162387 and expiration dates between February 16, 2017, and July 3, 2018.

The recall was initiated after routine monitoring of complaints revealed that the rate of distal tip bends and kinks for this specific model was higher than anticipated in the company's product risk documentation. The IntellaTip MiFi XP Catheter is indicated for the interruption of accessory atrioventricular conduction pathways associated with tachycardia, treatment of AV nodal reentrant tachycardia, treatment of atrial flutter tachycardia, and creation of complete AV block in patients with rapid ventricular response to atrial arrhythmia.

The affected devices were distributed worldwide, including nationwide in the United States and internationally to countries such as 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. Healthcare providers and patients should contact Boston Scientific for further instructions regarding the return or replacement of these devices.

The recalled product

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, f
Manufacturer
Boston Scientific Corp
Category
Medical Device — Cardiac Catheter
Hazard
Affected units
1,556

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Material Number: M004EPM4500N40
  • Catalog number: EPM4500N4
  • Lot numbers: 16743760
  • 17135083
  • 17614450
  • 18140623
  • 18162387. Expiration Date Range: 2/16/2017 to 7/3/2018.

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Boston Scientific Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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