Health product recall

Endo GIA Autosuture Universal Loading Unit Articulating (2020-08-18)

Starting date:
August 18, 2020
Posting date:
September 4, 2020
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-73863

Last updated:
2020-09-04

Affected Products

Endo GIA Autosuture Universal Loading Unit Articulating

Reason

This voluntary recall is being conducted following receipt of one confirmed customer report that the device staples were not properly formed upon application preventing adequate hemostasis. Our investigation identified a potential for a manufacturing assembly error that can contribute to staple malformation. The affected devices were distributed between June 2017 and July 2020. Use of a product with this assembly error may result in incomplete staple formation. In   thoracoscopic/laparoscopic cases, this could cause significant hemorrhage including hemothorax and hemoperitoneum potentially requiring an urgent conversion to open surgery. The potential also exists for bleeding, anastomotic leak, pneumothorax or other delayed secondary complications including infection, peritonitis, sepsis and an increased risk of mortality. Manufacturing process improvements have been implemented to remediate this issue.

Affected products

Endo GIA Autosuture Universal Loading Unit Articulating

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 30450
  • 30451
  • 30452
  • 30453
  • 30454
  • 30455
  • 30457
  • 30458
Companies
Manufacturer

Covidien LLC

15 Hampshire Street

Mansfield

02048

Massachusetts

UNITED STATES