Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36826 |
| Brand Name: | CRE Balloon Dilatation Catheter family |
| Model: | CRETM Wireguided and CRE PROTM Balloon Dilation Catheters |
| Affected: | Multiple lots |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Boston Scientific Corporation |
| Issue: | The manufacturer 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. aints 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. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/5/2026 |
