*
On 2023, Getinge voluntarily issued a safety notice regarding intra-aortic balloon pump catheters.
The problem affects the insertion kit.
On occasions, the sheath fractures at the connector, leaving the dilator body lodged inside the sheath. If this event occurs during IABP catheter insertion, the sheath and dilator assembly should be removed. Surgical extraction may be necessary at times.
The company's recommendations are as follows:
a) Insertion can be performed using alternative sheath.
Ideally reinforced with wire and 1 French diameter larger than the IABP catheter and a length of 10-15.2cm.
b) IABP catheter insertion with the sheathless technique.
OR
c) Return the IABP catheter along with its insertion kit to the company.