Hong Kong Issues Alerts for Blade Impactor, Catheter

January 6, 2017

Hong Kong’s Department of Health issued safety alerts for Synthes GmbH’s PFNA Blade Impactor, Boston Scientific’s Imager II Angiographic Catheter and Express LD Biliary Stent.

Synthes GmbH is recalling its Impactor for PFNA Blade following complaints that the handle detached from the shaft of the device due to a weld failure.

The PFNA impactor is part of the PFNA and PFNA-II systems used for treating high energy fractures in younger patients and low energy fractures in older patients. It is used to insert the PFNA blade by applying gentle blows with a hammer to the distal end of the impactor.

Infection could result if the handle is loosened from the shaft and allows body fluids to get inside the handle. In addition, the hidden debris could enter the surgical site of subsequent patients during surgery. Irrigants used during surgery may also loosen or liquefy the debris and potentially contaminate the surgical site.

Read the notice here: www.fdanews.com/12-16-16-impactor.pdf.

Angiographic Catheters

Boston Scientific is voluntarily recalling a single lot of its Imager II Angiographic Catheters due to packaging mislabeling. The affected lot was mislabeled as Imager II Contra 2 curve catheters when it actually contained Contra curve catheters.

Users can easily detect the problem and exchange the device, and there have been no reports of patient injuries. The affected products are not distributed in Hong Kong.

Read the notice here: www.fdanews.com/12-22-16-catheters.pdf.

Biliary Stent

Boston Scientific also issued a safety alert concerning its Express LD Biliary Stent, due to incorrect electronic instructions for use. The instructions included with the products refer to information on Boston Scientific’s e-labeling website that is pertinent to the U.S., and which contains indications that are not approved by Health Canada.

Read the notice here: www.fdanews.com/12-22-16-stent.pdf.