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.
- Product Names: Synergy Cranial and StealthStation S7 Cranial Software
- Model Numbers: See Recall Database Entry
- Distribution Dates: May 1, 2019 to October 29, 2021
- Devices Recalled in the U.S.: 943
- Date Initiated by Firm: November 11, 2021
The StealthStation System, with Synergy Cranial software or StealthStation S7 Cranial software, aids in precisely locating anatomical structures in neurosurgical procedures.
Reason for Recall
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.
Who May Be Affected
- Health care providers using Medtronic Synergy Cranial and StealthStation S7 Cranial Software
- Patients receiving care using Medtronic Synergy Cranial and StealthStation S7 Cranial Software
What to Do
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 at 1-888-826-5603 or email at firstname.lastname@example.org.
- 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 at email@example.com or by fax at 651-367-7075 within 30 days of receipt.
- Maintain a copy of the letter in your records.
Customers with questions about this recall should contact Medtronic Technical Services at 1-888-826-5603 or email at firstname.lastname@example.org.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.