Endo GIA: Ultra Articulating Sulu w/Tri-Staple Technology Med/Thick and Med/Thick Dissect, Reload w/Tri-Staple Technology Med/Thick, Curved Tip Reload w/Tri-Staple Technology Medium/Thick (2019-05-16)
- Starting date:
- May 16, 2019
- Posting date:
- June 7, 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-70125
Last updated: 2019-06-07
Affected Products
- Endo GIA Ultra Articulating Sulu w/Tri-Staple Technology Med/Thick
- Endo GIA Ultra Articulating Sulu w/Tri-Staple Technology Med/Thick Dissect
- Endo GIA Reload w/Tri-Staple Technology Med/Thick
- Endo GIA Curved Tip Reload w/Tri-Staple Technology Medium/Thick
Reason
This voluntary recall is being conducted due to the potential for a device to be missing one of two pin components that maintain alignment of the device jaws. The affected devices were distributed between april 2014 and april 2019. Use of a product without a pin may result in incomplete staple formation, potentially leading to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis. This potential issue was identified during in-process quality testing at the manufacturing facility. Manufacturing process improvements have been implemented to address this issue.
Affected products
A. Endo GIA Ultra Articulating Sulu w/Tri-Staple Technology Med/Thick
Lot or serial number
All lots.
Model or catalog number
EGIA30AMT
EGIA45AMT
EGIA60AMT
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
B. Endo GIA Ultra Articulating Sulu w/Tri-Staple Technology Med/Thick Dissect
Lot or serial number
All lots.
Model or catalog number
EGIA60CTAMT
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
C. Endo GIA Reload w/Tri-Staple Technology Med/Thick
Lot or serial number
All lots.
Model or catalog number
EGIA30AMT
EGIA45AMT
EGIA60AMT
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
D. Endo GIA Curved Tip Reload w/Tri-Staple Technology Medium/Thick
Lot or serial number
All lots.
Model or catalog number
EGIA45CTAMT
EGIA60CTAMT
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES