The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Synergy Cranial Software and Stealth Station S7 Cranial Software
- Model Numbers:
- 9733763 with software versions 2.2.0, 2.2.5, 2.2.6, 2.2.7
- 9735585 with software versions 3.0.0, 3.0.1, 3.0.2, 3.1.0
- Manufacturing Dates: August 31, 2011, to October 16, 2018
- Distribution Dates: August 31, 2011, to October 16, 2018
- Devices Recalled in the U.S.: 5487
- Date Initiated by Firm: September 26, 2018
The Synergy Cranial Software and StealthStation S7 Cranial Software, used with the StealthStation Surgical Navigation System, provides detailed three-dimensional (3D) images of a patient's brain to help neurosurgeons safely navigate surgical tools and implants used during brain surgery.
Reason for Recall
Medtronic is recalling the Synergy Cranial Software and StealthStation S7 Cranial Software used with the StealthStation Surgical Navigation System due to reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm.
During a biopsy procedure, the software monitor may show that the tip of the surgical tool has not yet reached the planned target and may prevent the neurosurgeon from being able to accurately see the location of surgical tools in the patient's brain. In the event this software defect occurs, the neurosurgeon could potentially insert the surgical tool too deeply and damage the patient's healthy tissue, brain or blood vessels.
Who is affected?
- Neurosurgeons and other trained medical personnel using the Synergy Cranial Software and StealthStation S7 Cranial Software to perform neurosurgical procedures.
- Patients undergoing a neurosurgical procedure using the Synergy Cranial Software and StealthStation S7 Cranial Software to perform neurosurgical procedures.
What to Do
On September 21, 2018, Medtronic sent an Urgent Medical Device Correction notice to customers. The notice provided the following mitigation to eliminate the risk of damaging healthy tissue:
- Do not set a projection longer than the length of the surgical plan.
- Follow the Cranial Software Pocket Guide, and always use the Biopsy Needle Mechanical Depth Stop.
- Ensure the Navigate Instrument Tip setting is selected prior to locking the trajectory and navigating the instrument.
The notice also instructed customers to take the following actions:
- Review the notice and ensure appropriate staff are aware of the issue.
- Sign and date the Consignee Response Form attached to the notice, and return the form to Medtronic by email at RS.NavFCA@Medtronic.com or fax to Medtronic Technical Services at 651-367-7075 within 30 days of receipt.
On December 28, 2018, Medtronic reported they were continuing to follow up with customers about their Urgent Medical Device Correction over the next months.
Customers who have questions or need additional information or support related to this recall should contact Medtronic Technical Services at 1-888-826-5603.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.