Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:28262
Brand Name:CS-DLP Left Heart Vent Catheter
Model:DLP® Left Heart Vent Catheters, 16 Fr - model number - 12116
Affected:
Software version:
Recalling Organisation:Medtronic New Zealand Limited
Unit 16 Mezzanine Level
5 Gloucester Park Road
Onehunga
AUCKLAND
Contact Information:0800 377 807
Manufacturer:Medtronic Inc
Brand Name:CS-DLP Left Heart Vent Catheter
Model:DLP® Left Heart Vent Catheters, 18 Fr - model number - 12118
Affected:
Software version:
Recalling Organisation:Medtronic New Zealand Limited
Unit 16 Mezzanine Level
5 Gloucester Park Road
Onehunga
AUCKLAND
Contact Information:0800 377 807
Manufacturer:Medtronic Inc
Issue:The manufacturer is recalling specific models of unused DLP® Left Heart Vent Catheters, 16 Fr (model 12116) and 18 Fr (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.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:27/8/2021
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