Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Rezūm System [REZUM DELIVERY DEVICE (C2) Part Number (UPN): D2201-003 GTIN: 855357006010, REZUM DELIVERY DEVICE UPN: M006D2201-003 GTIN: 8714729992547, REZUM GENERATOR US-CAN UPN: G2200-003 GTIN: 855357006003, REZUM GENERATOR US-CAN-EVAL UPN: G2200-003D GTIN: 8714729986850, REZUM GENERATOR US-CAN-HOSPITAL OWNED Part Number UPN: G2200-003H GTIN: 8714729986867, REZUM GENERATOR US-CAN-REPAIR UPN: G2200-003R GTIN: 8714729986843, REZUM GENERATOR US-CAN -ZERO COST Part Number (UPN): G2200-003Z GTIN: 8714729986874]
The manufacturer is initiating a voluntary product advisory in Canada regarding the Rezūm System, which consists of the Rezūm Delivery Device Kit for Benign prostatic hyperplasia (BPH) and Rezūm Generator, due to an error in the Indications for Use statement provided in the electronic Instructions for Use (eIFU) on the manufacturer website on the Canada portal.
The eIFU incorrectly included the wording in italics in the following indications for use and did not include "men ≥ 50 years of age":
The eIFU has been corrected to include the indications for use approved by Health Canada:
The updated eIFU can be located on the manufacturer's website: www.bostonscientific-elabeling.com.
The manufacturer has determined that this discrepancy poses no foreseeable risk to patient safety. Customers are not required to return product to the manufacturer.
According to the local supplier, the affected products are NOT distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 24 Aug 2021