Heart Vent Catheter, Atrial and Ventricular (2014-10-17)

Starting date:

October 17, 2014

Posting date:

October 29, 2014

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-41971

• 
  Reason
• 
  Affected products

Recalled Products

A) Heart Vent Catheter, Atrial

B) Heart Vent Catheter, Ventricular

Reason

Edwards LifeSciences has identified a potential patient safety risk which may occur during the use of venting catheters. The malleable Stylet which aids during insertion of the vent catheter is coated with a white plastic. The white plastic on the Stylet has the potential to become damaged through interaction with the hard plastic suction adapter on the vent catheter. This can result in the disruption of the white plastic coating on the Stylet. There is an increased chance of generating particulate if the Stylet is withdrawn with sharp bends and/or reinserted into the vent catheter. Reinsertion may lead to an increased potential for particulate to enter the vasculature. No injury has been associated with the use of this device. As a result Edwards is adding warnings to the instructions for use included with the affected device models.

Affected products