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
- Emerge Monorail PTCA Dilatation Catheter
- 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
- 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