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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00697-1
Product Name/Description STATLOCK IAB Stabilisation Device
(offers needle-free securement for intra-aortic balloon (IAB) catheters)

Macquet Part Number: 0065-00-0704

Products affected

All lot numbers from 3000001484 to 3000024495

ARTG Number: 139645
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 8/06/2016
Responsible Entity Maquet Australia Pty Ltd
Reason/Issue During post-quarantine packaging it was identified that the IFU for the STATLOCK Sheath Stabilisation Device for Percutaneous Sheath Introducers was erroneously packaged with the MEGA and SENSATION PLUS IAB Catheter Kits, instead of the IFU for the STATLOCK Catheter Stabilisation Device for IAB Catheters.
Recall Action Recall for Product Correction
Recall Action Instructions Maquet is advising users to inspect and identify the affected stocks. The IFU from the affected units should be removed and disposed prior to the use of the device. Affected customers can obtain a copy of the correct IFU by visiting the Maquet website at , by scanning the QR code in the customer letter or by contacting the customer's local Maquet representative. This action has been closed-out on 11/05/2017.
Contact Information 1800 605 824 - Director of Post-market