CLASS I ONGOING Device recall · Reported 14 Jun 2023 · FDA Enforcement Report

StealthStation Cranial recalled by Medtronic Navigation

Medtronic Navigation is recalling StealthStation Cranial, distributed in Puerto Rico. The recall was initiated on 11 Apr 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel/UDI-DI/Software Versions: 9735585/00763000253165, 00763000306762 (inside Kits: 00763000299927, 00763000299972), 00763000517267(inside Kits: 00763000517274, 00763000517335)/v3.1.1, 3.1.2, and 3.1.3

Quantity recalled556

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1666-2023
FDA event ID: 92269
Recalling firm: Medtronic Navigation, Lafayette, CO
Classification: Class I
Status: Ongoing
Recall initiated: 11 Apr 2023
FDA classified: 2 Jun 2023
Reported: 14 Jun 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Medical Software

Timeline

11 Apr 2023	Recall initiated by company
2 Jun 2023	Classified by FDA	+52 days
14 Jun 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance to/past target text no longer synchronized with navigation information, inaccurate value displayed; may result in prolonged/additional procedure, tissue injury

Product as listed by the FDA

StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems

Where it was distributed

US Distribution: PR. OUS (foreign) distribution: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BOSNIA and HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, Colombia COLOMBIA, C¿TE D'IVOIRE, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, LATVIA, MEXICO, MOLDAVIA, NETHERLANDS, PAKISTAN, POLAND, PORTUGAL, REPUBLIC of KOREA, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES

Puerto Rico

Stores named: Target

Questions about this recall

Is StealthStation Cranial recalled?

Yes. Medtronic Navigation recalled StealthStation Cranial on 11 Apr 2023. The recall is Class I and its status is Ongoing. Recall number Z-1666-2023.

Why was it recalled?

Which lots are affected?

Model/UDI-DI/Software Versions: 9735585/00763000253165, 00763000306762 (inside Kits: 00763000299927, 00763000299972), 00763000517267(inside Kits: 00763000517274, 00763000517335)/v3.1.1, 3.1.2, and 3.1.3

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Medtronic Navigation

All 92

Reported	Class	Recall	Company	Reason	Where
5 Feb 2025Device	CLASS II	Medtronic Pin Sterile Percutaneous recalled by Medtronic Navigation	Medtronic Navigation	Sterility	Nationwide
16 Oct 2024Device	CLASS II	StealthStation S8 App versions 3.0 and 3.2 recalled	Medtronic Navigation	Device Malfunction	Nationwide
15 May 2024Device	CLASS I	Stealth S8 Clinical recalled by Medtronic Navigation	Medtronic Navigation	Device Malfunction	Nationwide
17 Jan 2024Device	CLASS II	Medtronic, REF 9733236, Pin, 150mm, Sterile, Percutaneous recalled	Medtronic Navigation	Sterility	Nationwide
17 Jan 2024Device	CLASS II	Medtronic, REF 9733235, Pin, 100mm, Sterile, Percutaneous recalled	Medtronic Navigation	Sterility	Nationwide

Other Medical Software recalls

All 903

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips IQon Spectral CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Ingenuity CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled	Philips North America	Device Malfunction	MA
8 Sep 2026Device	ANNOUNCED	BMC Luna G3 APAP recalled by BMC MedicalBMC	BMC Medical	Device Malfunction	Nationwide