Advanix Pancreatic Stent (2019-10-21)

Starting date:

October 21, 2019

Posting date:

November 15, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71607

Last updated: 2019-11-15

• 
  Reason
• 
  Affected products

Affected Products

Advanix Pancreatic Stent

Reason

Boston Scientific is initiating a voluntary removal of certain Advanix Pancreatic Stents because the "use by date" displayed on the labels of affected products is incorrect and is later than the actual "use by date". Some devices in distribution have surpassed the correct "use by date". While the "use by date" is incorrect, there are no adverse health consequences expected to occur. Boston Scientific has data to support both that the Advanix Stent performs as intended and that the packaging maintains the sterile barrier of the device through a 36-month timeframe, if used by the incorrect "use by date". Due to this the affected Advanix Pancreatic Stents that have been implanted do not require special follow-up or monitoring.

Affected products