Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Crania
Summary
The FDA issued a Class I for Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or Syn by Medtronic Navigation, Inc.. Reason: Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational informati.
Details
Source
Device Recall
External ID
Z-0383-2022
Action Date
2021-12-29
Status
Ongoing
Category
device
Product Description
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/Code Info: 9733763, Version: 2.2.8; 9735585, Versions: 3.1.1, 3.1.2, 3.1.3
Quantity Affected: 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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-11
Company
Louisville, CO
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 113 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Navigation, Inc. has 23 FDA actions in our database, including 13 recalls and 10 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Navigation, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Navigation, Inc. have FDA actions?
Medtronic Navigation, Inc. has 23 FDA actions in our database, including 13 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0383-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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