Endo GIA Reload w/Tri-Staple Technology Med/Thick, Endo GIA Curved Tip Reload w/Tri-Staple Technology Vascular and Vascular/Medium, and Endo GIA Gray Articulating Reload Extra Thin/Vascular (2018-05-23)
- Starting date:
- May 23, 2018
- Posting date:
- June 6, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66988
Affected products
- Endo GIA Reload w/Tri-Staple Technology Med/Thick
- Endo GIA Curved Tip Reload w/Tri-Staple Technology Vascular/Medium
- Endo GIA Curved Tip Reload w/Tri-Staple Technology Vascular
- Endo GIA Gray Articulating Reload Extra Thin/Vascular
Reason
Covidien LLC is conducting a voluntary recall due to use of misassembled (reversed) sled components. When the device is applied to tissue and fired, a misassembled sled may result in the tissue being transected without the deployment of staples to seal the point of transection. This may result in bleeding, immediate anastomotic leak and potential for death if this is used on a critical vascular structure such as the pulmonary artery and renal artery.
Affected products
A. Endo GIA Reload w/Tri-Staple Technology Med/Thick
Lot or serial number
- N7M0047KX
- N7M0617KX
- N7M1001KX
- N8A0203KX
Model or catalog number
- EGIA45AMT
- EGIA60AMT
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
B. Endo GIA Curved Tip Reload w/Tri-Staple Technology Vascular/Medium
Lot or serial number
- N7L1041KX
- N8A0199KX
Model or catalog number
EGIA45CTAVM
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
C. Endo GIA Curved Tip Reload w/Tri-Staple Technology Vascular
Lot or serial number
- N7L0818KX
- N7L0819KX
Model or catalog number
- EGIA30CTAV
- EGIA45CTAV
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
D. Endo GIA Gray Articulating Reload Extra Thin/Vascular
Lot or serial number
- N7L0823KX
- N8A0799KX
Model or catalog number
EGIA45AV
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES