Beacon EUS Access System Preloaded 90? Access Needles (2020-07-08)
- Starting date:
- July 8, 2020
- Posting date:
- August 14, 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-73679
Last updated:
2020-08-14
Affected Products
Beacon EUS Access System Preloaded 90? Access Needles
Reason
This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.
Affected products
Beacon EUS Access System Preloaded 90? Access Needles
Lot or serial number
F2510900X
F2512378X
Model or catalog number
DSA-090-01
DSA-135-01
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES