Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning Atlantis PV 15 MHz Peripheral Imaging Catheter. Details of affected products are as follows:

• Material number (UPN): H749364560
• Catalogue number: 36456
• Lot numbers: 16159358, 16183964, 16230195, 16230673, 16247263, 16257809, 16268498, 16289177, 16311356, 16330543, 16342824, 16419885, 16420624, 16420903, 16447744, 16458536, 16486133, 16494530
• Expiration date: 11 Jun 2014 to 29 Oct 2014

The manufacturer has become aware that the manifold of certain lots may be blocked by excess bonding adhesive. A blocked manifold may prevent affected catheter from advancing over the guidewire resulting in a delay in procedure while the device is exchanged for another unit.

The manufacturer advises users to discontinue the use of and segregate the recalled product immediately. The product should be returned to the manufacturer for replacement.

According to the local supplier, the affected products were not distributed in Hong Kong.

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 17 January 2014