Health product recall

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

  1. Endo GIA Reload w/Tri-Staple Technology Med/Thick
  2. Endo GIA Curved Tip Reload w/Tri-Staple Technology Vascular/Medium
  3. Endo GIA Curved Tip Reload w/Tri-Staple Technology Vascular
  4. 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

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