The Recall Desk
HighFDA (Devices)·Z-1966-2020·Announced 2020-05-20

Magstim Recalls Rapid2 Stim Interconnecting Cables Due to Potential Failure

The Magstim Company Limited is recalling 71 Rapid2 PSU Stim Interconnecting Cables because the high-voltage cable may fail. The recall covers units distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-voltage cable failure in a medical device, which presents a risk of harm (electrical shock or equipment malfunction) even though no specific injuries are reported in the source text.

Plain-English summary

The Magstim Company Limited is recalling 71 units of the Rapid2 PSU Stim Interconnecting Cable. The product is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The recall was initiated because it was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail. The affected product code is 3853-00.

The recall includes units distributed worldwide, including in the United States and various international locations. No specific instructions for consumers are provided in the source text.

The recalled product

Product
Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Manufacturer
The Magstim Company Limited
Category
Medical Device — Neuromodulation
Hazard
Affected units
71

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product Code: 3853-00

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Part of a larger recall action

This product is one of 2 recalled by The Magstim Company Limited under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · The Magstim Company Limited

See all →

Same hazard · electrical failure

See all →