Agency classClass IOur severity:Severe FDA (Devices)·Z-0383-2022·Announced 2021-12-29

Stealthstation and Synergy Cranial surgical navigation system software synchronization error

Stealthstation and Synergy Cranial surgical navigation systems may display an incorrect biopsy needle position due to software synchronization failure. This could result in prolonged surgery, additional procedures, or tissue injury.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which per the rubric requires a minimum severity score of 4. The defect involves incorrect needle positioning during surgical procedures with potential for tissue injury and additional surgical procedures.

Plain-English summary

Medtronic Navigation, Inc. is recalling certain Stealthstation and Synergy Cranial surgical navigation systems due to a software defect. The affected systems include Stealthstation Cranial (Model 9735585) with software versions 3.1.1, 3.1.2, or 3.1.3, and Synergy Cranial (Model 9733763) with software version 2.2.8.

The biopsy depth gauge in these systems may become desynchronized from the rest of the navigational information displayed on the screen. When this occurs, the system may display an incorrect position of the biopsy needle during a cranial biopsy procedure. This defect could result in a prolonged procedure, the need for additional surgical procedures, or tissue injury.

Approximately 2,587 units of the affected systems have been distributed to healthcare facilities across the United States and internationally, including countries in Europe, Asia, the Middle East, and other regions.

The recalled product

Product: Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585
Manufacturer: Medtronic Navigation, Inc.
Category: Medical Device — Surgical Navigation System
Hazard: software-malfunction
needle-misposition
tissue-injury
Affected units: 2,587

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

9733763
Version: 2.2.8
9735585
Versions: 3.1.1
3.1.2
3.1.3

Distribution

Distributed in 51 states:

Same manufacturer · Medtronic Navigation, Inc.

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