01 Jun CRE™ Wireguided Balloon Dilatation Catheter
| Company name & Address: | registration number | Batch number(s) | Expiry date | Pack size | First release date | Re-call Classification | Recall date |
| Boston Scientific
No. 8 Anslow Crescent Anslow Office Park Bryanston 2021 |
N/A |
See Recall Letter |
See Recall Letter |
1 unit |
18 August 2021 |
Class II Type B |
27 May 2026 |
Brief description of the problem (reason for recall)
Boston Scientific is initiating recall of CRETM Wireguided, CRE PROTM Wireguided, and CRE PRO GITM Wireguided balloon dilation catheters due to a potential sterile breach of the pouches in which the devices are packaged.
Advice for health professionals and distributors:
1- Please immediately discontinue use of the Boston Scientific product reported in the list and remove all of the affected units from your inventory, regardless of where these units are stored in your facility. Segregate the units in a secure place, pending return to Boston Scientific.
2- Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device.
3- Please complete the attached Verification Form attached to the recall letter even if you do not have any product to return.
4- When completed, please return the Verification Form to your local Boston Scientific office for the attention of <Customer_Service_Fax_Number> on or before 10 June 2026.
5- If you have products to return, please package them in an appropriate shipping box. After receipt of the Verification Form, Boston Scientific will contact you to arrange return.
6- Please pass this notice to any health professional from your organization that needs to be aware and to any organization where the potentially affected devices have been transferred (if appropriate). Please provide Boston Scientific with details of any affected devices that have been transferred to other organizations (if appropriate).
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.