FDA Device Recall Z-0383-2022

Medtronic Navigation, Inc. · Louisville, CO

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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

Lot / serial / GTIN: 9733763, Version: 2.2.8; 9735585, Versions: 3.1.1, 3.1.2, 3.1.3

Quantity: 2587

Reason for recall

Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy needle, which may result in prolonged procedure, the need for additional surgical procedure, tissue injury.

Recall record

Recall number: Z-0383-2022
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US: MN, FL, MD, IL, AK, NE, NH, PA, ND, AR, CA, WI, NJ, GA, SD, AZ, KY, AL, MS, MO, TX, MI, MT, OH, NY, VA, MA, CT, TN, WV, WA, NC, CO, NV, ME, LA, DE, NM, IN, UT, DC, OR, SC, OK, IA, HI, ID, KS, WY, MN, PR OUS: AU, BN, GU, JP, KR, MY, NZ, SG, TH, VN, MM, CA, CZ, RU, AL, CY, DE, ES, FR, GB, HU, IL, IT, NL, PL, RO, CN, HK, TW, IN, LK, NP, AR, BB, BR, CL, CO, CR, DO, EC, MX, PE, PR, VE, NI, UY, AE, BH, DZ, EG, IQ, JO, KZ, KE, SA, LB, LY, MA, NA, PK, QA, ZA, TR, AT, BE, CH, DK, FI, GF, GR, IE, LV, LT, LU, PT, SE, SK, UK, BA, BG, CI, HR, RS, SI
Recall initiated: 2021-11-11
Classified by FDA Center: 2021-12-22
FDA published: 2021-12-29
Recalling firm: Medtronic Navigation, Inc.
Firm location: Louisville, CO

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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