StealthStation Cranial recallZ-1630-2023 · Medtronic Navigation, Inc. · initiated Apr 11, 2023

Why it was recalled

During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information showing inaccurate values, which may result in prolonged/additional procedure, tissue injury

FDA root cause category: Software design

What the company is doing

On 4/11/23, correction notices were sent to healthcare professionals that were advised of the following; 1) Do not utilize the following: a) Biopsy Depth Gauge Graphic in Cranial Biopsy procedures. In accordance with the IFU: Frequently confirm navigation accuracy and system responsiveness during live navigation. Use the navigation instrument to touch several bony anatomical landmarks and confirm that the locations identified on the images match the locations touched on the patient. If accuracy degrades, re-register the patient. Always use the Biopsy Needle Mechanical Depth Stop. If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system. b) Distance to/past Target value for Tumor Resection, Shunt Placement, and DBS procedures. Per the IFU: "Warning: Frequently confirm navigation accuracy and system responsiveness during live navigation. Use the navigation instrument to touch several bony anatomical landmarks and confirm that the locations identified on the images match the locations touched on the patient. If accuracy degrades, re-register the patient." and "If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system." 2) All physician users should review the correction notice. Pass on the notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. 3) Complete and return the customer confirmation form that can be returned to [email protected]. Firm will provide warning and instructional placards to be applied to the affected systems. Firm is currently working on a software update and will communicate additional information when it becomes available. If you have any questions related to this issue, contact Technical Services for help at: 1-888-826-5603 or email at [email protected]

Recall details

Recall number

Z-1630-2023

Status

Open, Classified

Initiated by the company

Apr 11, 2023

Posted by the FDA

Jun 2, 2023

Recalling firm

Medtronic Navigation, Inc.

Quantity

746

Product code

HAW

FDA submissions

K221087

Distribution

Worldwide Distibution: US (nationwide): OH, IL, CA, MI, FL, LA, OK, WA, AR, NJ, MN, MO, WI, MA, ND, NY, MD, OR, AK, NE, TN, AZ, IN, GA, GU, VA, PA, TX, SD, MT, NV, MS, KY, AL, CT, WV, KS, IA, NC, UT, CO, NH, DC, WY. OUS (foreign): ALBANIA, ARGENTINA, Australia, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, Bosnia and Herzegovina, BULGARIA, CANADA, CHILE, CROATIA, CZECH REPUBLIC, DENMARK, FRANCE, GREECE, INDIA, IRELAND, ITALY, JAPAN, LUXEMBOURG, MARTINIQUE, NEW ZEALAND, POLAND, PORTUGAL, Republic of Korea, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVAKIA, SPAIN, SWITZERLAND, TAIWAN, Turkey, UNITED ARAB EMIRATES, UNITED KINGDOM

Product description

StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• StealthStation® Cranial 9735586

  Medtronic Navigation, Inc. · Neurological stereotaxic Instrument
  1 recall0 reports
• StealthStation® Cranial 9735587

  Medtronic Navigation, Inc. · Neurological stereotaxic Instrument
  1 recall0 reports

Product lines

• StealthStation CranialMedtronic Navigation, Inc. · 13 models · 2 reports · 3 recalls