Balloon Guide Catheter (2018-11-13)

Starting date:

November 13, 2018

Posting date:

January 9, 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-68642

• 
  Reason
• 
  Affected products

Affected products

Balloon Guide Catheter

Reason

On Oct. 10, 2018 at the point of product use in Czech Republic, three units from UPN 90074, lot# 0000010779 with 9F packaging and pouching labels were found to have BGC 8F merci products in them. The neurovascular complaint team in Fremont, ca became aware of this issue on Oct. 11, 2018. All were noted during preparation, there was no patient involvement.

Affected products