Medtronic is recalling specific models of unused DLP Left Heart Vent Catheters,
16 Fr (model 12116) and 18Fr (model 12118)
due to the potential for a wire protrusion through the left heart vent catheter tip. If unnoticed prior to the procedure, this wire protrusion could lead to tissue damage (abrasion / perforation) and thereby to a longer duration of the procedure and/or surgical repair.
Note the Date is incorrect on the image below and should read 30 August 2021
PIRS2 : Human Factors of Reporting Information
Reproduced with permission from JECT
Timothy W. Willcox, CCP;* Robert A. Baker, PhD, CCP^
*Green Lane Cardiothoracic Unit, Auckland City Hospital, Auckland, New Zealand; and Department of Anaesthesiology, School of Medicine, University of Auckland, Auckland, New Zealand; and ^Cardiac and Thoracic Surgery Unit, Flinders Medical Centre, Adelaide, South Australia; College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
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