01 Jun Bobby Balloon Guide Catheter
| Company name & Address: | registration number | Batch number(s) | Expiry date | Pack size | First release date | Re-call Classification | Recall date |
| Intramed
12 Huklingham Road Dunkeld West 2196 |
N/A |
See Recall Letter |
Not Available |
1 |
Not Available |
Class II Type C |
19 May 2026 |
Brief description of the problem (reason for recall)
This action is based on complaints identified through established proactive post-market surveillance processes that have generated signal concerns which may impact the patient safety profile of BOBBY Balloon Guide Catheter.
Advice for health professionals and distributors:
- For Distributors, please provide this letter to the medical facilities or physicians to whom you have distributed recalled product(s).
- Please complete, and return the “Customer Acknowledgment form” via email to bobbyrecall@expertinquiry.com
- Please reconcile and return the recalled products.
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.