Health product recall

Emerge Monorail PTCA Dilatation Catheter & NC Emerge PTCA Dilatation Catheter (2019-10-28)

Starting date:
October 28, 2019
Posting date:
November 22, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-71676

Last updated: 2019-11-22

Affected Products

  1. Emerge Monorail PTCA Dilatation Catheter
  2. NC Emerge PTCA Dilatation Catheter

Reason

Voluntary removal of certain dilation and extension catheters. Specific batches of these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

Affected products

  1. Emerge Monorail PTCA Dilatation Catheter

Lot or serial number
  • 20909603
  • 21363021
  • 22619082
  • 23181062
  • 23901505
  • 23924000
Model or catalog number
  • H7493918912300
  • H7493918915150
  • H7493918915300
  • H7493918915350
  • H7493919315200
  • H7493919315250
Companies
Manufacturer

Boston Scientific Corporation

300 Boston Scientific Way

Marlborough

01752

Massachusetts

UNITED STATES

B. NC Emerge PTCA Dilatation Catheter

Lot or serial number

23541260
23998683

Model or catalog number

H7493926712250
H7493926715350

Companies
Manufacturer

Boston Scientific Corporation

300 Boston Scientific Way

Marlborough

01752

Massachusetts

UNITED STATES