Health product recall

microTargeting Drive System, STar Drive System (2018-04-29)

Starting date:
April 29, 2019
Posting date:
May 31, 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-70055

Last updated: 2019-05-31

Affected Products

  1. microTargeting Drive System
  2. microTargeting Drive System
  3. microTargeting STar Drive System

Reason

microTargeting Depth Stop is being recalled which is a component of microTargeting STar Drive System and microTargeting Drive System. It has been sold individually and as part of the system.  After analysis of several complaints of lead damage it was determined that, the user overtightened the depth stop screw onto the lead, despite the warning in DFU. FHC determined to replace depth stops proactively and determined field corrective action is the best way.

Affected products

A. mIcroTargeting Drive System

Lot or serial number

Not applicable.

Model or catalog number

66-AC-DS(1.8)

Companies
Manufacturer
FHC, Inc.
1201 MAIN STREET
BOWDOIN
Maine
UNITED STATES

B. mIcroTargeting Drive System

Lot or serial number

Not applicable.

Model or catalog number

FC1006

Companies
Manufacturer
FHC, Inc.
1201 MAIN STREET
BOWDOIN
Maine
UNITED STATES

C. microTargeting STar Drive System

Lot or serial number

Not applicable.

Model or catalog number
  • FC8001
  • FC8002
Companies
Manufacturer
FHC, Inc.
1201 MAIN STREET
BOWDOIN
Maine
UNITED STATES