The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0463-2016·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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect (tip bends/kinks) in a medical device used for cardiac procedures, which poses a risk of harm, but the source does not report specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Boston Scientific Corp is recalling 1,556 units of the IntellaTip MiFi XP Asymmetric (N4) Curve catheters. The recall affects specific material and catalog numbers, with expiration dates ranging from February 16, 2017, to July 22, 2017. The devices were distributed nationwide in the United States and internationally to various countries.

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.

Healthcare providers and patients should stop using the affected devices and contact Boston Scientific for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

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…
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 (4)

  • Material Number: M004EPM4790N40
  • Catalog number: EPM4790N4
  • Lot numbers: 16743398
  • 17135082.. Expiration Date Range: 2/16/2017 to 7/22/2017

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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