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
- microTargeting Drive System
- microTargeting Drive System
- 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