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Hercules 360 and Hercules 3 Universal Stabilizer Arms (2015-01-26)
- Starting date:
- January 26, 2015
- Posting date:
- February 6, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43571
Recalled products
- Hercules 360 Universal Stabilizer Arm
- Hercules 3 Universal Stabilizer Arm
Reason
If the cable breaks, the stainless steel links on the arm can fall off. There is potential that these links may fall into the surgical site. If a component falls into a patient's body cavity, it is unlikely to cause patient injury. The event could, however, lead to a delay in the procedure as the surgeon retrieves the component.
Affected products
A. Hercules 360 Universal Stabilizer Arm
Lot or serial number
Not applicable
Model or catalog number
- T401160
Companies
- Manufacturer
-
Terumo Cardiovascular System Corporation
125 Blue Ball Road
Elkton
21921
Maryland
UNITED STATES
B. Hercules 3 Universal Stabilizer Arm
Lot or serial number
Not applicable
Model or catalog number
- T401161
Companies
- Manufacturer
-
Terumo Cardiovascular System Corporation
125 Blue Ball Road
Elkton
21921
Maryland
UNITED STATES