| TGA Action ID |
RC-2026-RN-00386-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
CRE Wireguided and CRE PRO Balloon Dilation Catheters
Multiple product descriptions and lot numbers |
| ARTG Number |
271272 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Boston Scientific is initiating removal of CRE Wireguided and CRE PRO Wireguided balloon dilation catheters due to a potential sterile breach of the pouches in which the devices are packaged. These catheter products are primarily used to endoscopically dilate strictures of the alimentary tract.
The reported problem is highly detectable upon visual inspection of the silver side of the pouch. A total of 18 complaints have been received and of those, 1 unit was confirmed as a sterile breach. In all cases, no patients were impacted because the damage to the packaging was identified upon device receipt prior to use in a procedure. Out of the 18 complaints received to date, none have been reported within Australia. The most common adverse health consequence reasonably foreseeable to occur is a prolonged procedure of negligible severity to account for device exchange prior to the procedure. It is reasonable to expect that another of the same or a similar gastrointestinal dilatation balloon would be readily available for use as they are commonly stocked items in a facility where endoscopic procedures are performed. |
| Instructions for Customers/Users |
Customers should remove affected product from use and return it to Boston Scientific |
| Action Commencement Date |
21/05/2026 |
| Responsible Entity |
|
| Contact Information |
ANZ_Incident_Report@bsci.com - Boston Scientific |