SoloPath Transfemoral, Re-Collapsible Access Systems (2019-04-30)
- Starting date:
- April 30, 2019
- Posting date:
- May 10, 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-69896
Last updated: 2019-05-10
Affected Products
A. SoloPath Transfemoral Access System
B. SoloPath re-Collapsible Access System
Reason
Dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
Affected products
A. SoloPath Transfemoral Access System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- STFI-1435
- STFI-1625
- STFI-1825
- STFI-1835
- STFI-1925
- STFI-1935
- STFI-2135
Companies
- Manufacturer
-
Terumo Medical Corporation
950 Elkton Blvd
Elkton
21921
Maryland
UNITED STATES
B. SoloPath re-Collapsible Access System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- SR-1925
- SR-1935
- SR-2235
- SR-2425
- SR-2435
Companies
- Manufacturer
-
Terumo Medical Corporation
950 Elkton Blvd
Elkton
21921
Maryland
UNITED STATES