Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01192-1
Product Name/Description ACUITY Pro 9 Fr Guide Catheter
( used to access the coronary venous system for implantation of a left ventricular pacing lead)

Model Numbers: 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, 8119

Multiple Lot Numbers affected

ARTG Number: 222220
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 7/12/2015
Responsible Entity Boston Scientific Pty Ltd
Reason/Issue Boston Scientific is recalling certain lots of 9Fr ACUITY Pro Coronary Sinus Outer Guide Catheters due to potential for separation of the proximal handle from the shaft. Boston Scientific's investigation concluded that if the hub and shaft are aligned off-centre in the bonding equipment during manufacturing, the result may be a reduced bond, which may separate during cutting. The affected products were manufactured during the time period when the equipment was likely to be misaligned.

The most serious injury foreseeable with unexpected hub detachment is a moderate delay in the procedure to reposition a dislodged lead. Boston Scientific has received reports of handle separations during the cut and removal process; there have been no reports of patient harm.
Recall Action Recall
Recall Action Instructions Customers are advised to immediately segregate all affected products to ensure that it will not be used and to ship the stock back to Boston Scientific for replacement with unaffected stock. This action has been closed-out on 24/08/2016.
Contact Information 02 8063 8100 - Boston Scientific