Health Canada — Medical Devices · Canada · 2022-08-15 · Type II
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Reported risk: Notification to inform customers that in rare instances (0.085%) during initial programming, the Vanta CP app will display the error code 1502 message because the Vanta INS reset block id log is full. Once the log is full, all subsequent interrogations with the affected device will not be possible. If the error code 1502 message occurs, it will display during the next interrogation after the Vanta INS usage is started. Should this present at initial programming: • Surgery may be delayed to obtain an alternative INS, or surgery may be cancelled if an alternative INS is unavailable and the affected INS is not implanted. • It will not be possible to program the device so therapy cannot be initiated for newly implanted patients and patients receiving a replacement device may experience a return of underlying pain symptoms. • If the recommended cannot be performed, an unanticipated surgical intervention may be needed to explant and replace the INS. The issue is related to the Vanta CP app. The Vanta INS is performing as intended. If the INS has been previously programmed, it will continue to provide therapy to the patient within programmed parameters. Recall start date: August 2, 2022
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.