INTERSTIM SYSTEM - TEMPORARY PERIPHERAL NERVE EVALUATION KIT (2016-02-19)

Starting date:

February 19, 2016

Posting date:

March 29, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Hospitals, Healthcare Professionals

Identification number:

RA-57674

• Reason
• Affected products

Affected products 

A. INTERSTIM SYSTEM - TEMPORARY PERIPHERAL NERVE EVALUATION KIT

Reason

This action is being conducted due to the potential for a breach in the sterile packaging due to damage that may have occurred during transportation. This removal is intended to mitigate the risk for infection as a result of a potential breach in the sterile packaging. While the primary Peripheral Nerve Evaluation (PNE) lead and cable components have an additional sterile barrier separate from the tray, additional kit components used during the PNE lead implant procedure do not. Through 12 February 2016, Medtronic has not received any complaint reports related to this issue.

Affected products