FDA MedWatch - Synergy Cranial and StealthStation S7 Cranial Software by Medtronic:

U.S. Food and Drug Administration sent this bulletin at 01/07/2022 07:17 AM EST

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: Synergy Cranial and StealthStation S7 Cranial Software by Medtronic: Class I Recall - Due to Potential Risk of Inaccurate Biopsy Depth Gauge Cycle View

AUDIENCE: Patient, Health Professional, Risk Manager, Neurology

ISSUE: Medtronic is recalling its Synergy Cranial and StealthStation S7 Cranial software due to the potential inaccuracies caused by the Biopsy Depth Gauge Cycle View.

If the user encounters the software issue where the graphical Biopsy Depth Gauge is no longer synchronized with other navigation views, it may result in a prolonged procedure, the need for an additional surgical procedure, aborted procedure, tissue injury, including potential for life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.

There have been four complaints regarding this device issue. There have been no reported injuries or deaths.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The StealthStation System, with Synergy Cranial software or StealthStation S7 Cranial software, aids in precisely locating anatomical structures in neurosurgical procedures.

RECOMMENDATIONS: On November 11, 2021, Medtronic provided health care professionals with information related to the potential inaccuracy during biopsy procedures using the StealthStation S7 and i7 Biopsy Depth Gauge feature.

The letter requested customers to:

Review this information with all physician users.
If you have any questions related to this issue, contact Medtronic Technical Services.
Confirm with the Customer Confirmation Form that you understand Medtronic will provide a warning and instructional placard to be applied to impacted StealthStation Systems and that this notification has been communicated within your facility with all physician users.
Send the completed Customer Confirmation Form to Medtronic by email.
Maintain a copy of the letter in your records.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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