The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0465-2016·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 2/5 (Moderate).

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 illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Boston Scientific Corp is recalling the IntellaTip MiFi XP Asymmetric (N4) Curve catheters. The recall involves 1,556 total units across all models. The affected products are identified by Material Number M004PM4790N40 and Catalog number PM4790N4. Specific lot numbers include 16743269, 16818653, 16818654, 16872007, 16993525, 17511087, 18159904, and 18385792, with expiration dates ranging from September 1, 2016, to September 20, 2018.

The recall was initiated after Boston Scientific noted during routine complaint monitoring that the complaint rate for distal tip bends and kinks was above the anticipated rate documented in their product risk files. 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 products 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 recall.

The recalled product

Product
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for…
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 (10)

  • Material Number: M004PM4790N40
  • Catalog number: PM4790N4
  • Lot numbers: 16743269
  • 16818653
  • 16818654
  • 16872007
  • 16993525
  • 17511087
  • 18159904
  • 18385792. Expiration Date Range: 9/1/2016 to 9/20/2018. .

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 →

Related recalls

Same manufacturer · Boston Scientific Corp

See all →

Same hazard · structural defect

See all →

Similar recalls