19 May TCNTM (Thermo Couple Nitinol) and CSKTM (Cosman Straight Kit) Reusable Radiofrequency (RF) Electrodes
| Company name & Address: | Product Name(s) | 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
|
CSK TC ELECTRODE 10CM |
N/A |
All |
Not available |
Not available |
Not available |
Class II Type B |
14 May 2026 |
| CSK 10CM TC ELECTRODE WITH 3M CABLE | ||||||||
| CSK TC ELECTRODE 15CM | ||||||||
| CSK 15CM TC ELECTRODE WITH 3M CABLE | ||||||||
| CSK TC ELECTRODE 20CM | ||||||||
| CSK TC ELECTRODE 5CM | ||||||||
| CSK 5CM TC ELECTRODE WITH 3M CABLE | ||||||||
| NITINOL TC ELECTRODE 10CM | ||||||||
| NITINOL TC ELECTRODE 10CM 3M CABLE | ||||||||
| NITINOL TC ELECTRODE 15CM | ||||||||
| NITINOL TC ELECTRODE 15CM 3M CABLE | ||||||||
| NITINOL TC ELECTRODE 20CM | ||||||||
| NITINOL TC ELECTRODE 20CM 3M CABLE | ||||||||
| NITINOL TC ELECTRODE 5CM | ||||||||
| NITINOL TC ELECTRODE 5CM 3M CABLE |
Brief description of the problem (reason for recall)
This recall has been initiated due to TCNTM and CSKTM Reusable RF Electrodes not consistently meet the expected performance levels throughout the specified 20 sterilization cycles for re-use.
Advice for health professionals and distributors:
- 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.
- 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.
- Please complete the attached Verification Form on the Customer Recall Letter even if you do not have any product to return.
- If you have USED product on hand, discard them and select the option to indicate you have found USED affected product and have disposed of it.
- When completed, please return the Verification Form to your local Boston Scientific office for the attention of <Customer_Service_Fax_Number> on or before 20 May 2026.
- 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.
- 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.