Recall record at a glance
| Official record | Z-0593-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | St. Jude Medical, Inc. |
| Report date | Dec 19, 2018 |
| Recall initiation date | Oct 11, 2018 |
| Quantity | N/A |
| Location | Plano, TX, United States |
Official product description
St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano, TX St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 40 cm, 0.5 REF 6172 STERILE EO Rx ONLY St. Jude Medical Plano, TX Instructions For Use: Lead and Extension Kits for Deep Brain Stimulation Systems Clinician's Manual ST. JUDE MEDICAL - Product Usage: St. Jude Medical Deep Brain Stimulation (DBS)leads are intended to deliver stimulation to target areas in the brain. DBS extensions are intended to connect the leads to implantable pulse generators (IPGs). St. Jude Medical DBS leads are designed for introduction into the brain using standard stereotactic neurosurgical techniques. DBS system delivers electrical stimulation to a precisely targeted area in the brain. Leads are implanted in the brain and are connected to extensions, which are passed under the skin and are connected to the neurostimulator. Leads for the St. Jude Medical Infinity DBS System feature electrodes on a stiff distal end with an inactive lead tip. The proximal end of the lead contains contact bands that correspond with each of the distal electrodes and an inactive band that functions as a contact for a setscrew when connecting to a compatible extension. The 8-channel leads contain cylindrical and segmented electrodes. The segmented electrodes can be activated independently to focus stimulation in one direction to help target desired neurological structures. As stated in Clinician manual (ARTEN600008305 Rev A), leads materials which are intended to come into contact with tissue are Platinum-iridium and polycarbonate urethane. In addition, drawing for the Stim Tip, 1-3-3-1 Directional DBS lead requires that the electrode material shall be 90/10 Platinum Iridium.
Why the product was recalled
The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium.
Distribution information
Worldwide distribution - US nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, MD, MN, MO, MT, NC, NJ, NY, OH, PA, and WA. International distribution in the countries of Argentina, Australia, Austria, Belgium, Brazil, Colombia, Czech Republic, Finland, France, Germany, Hungary, Italy, Mexico, Poland, Russian Federation, Saudi Arabia, South Korea, Spain, Sweden, Taiwan, Turkey, and United Kingdom
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.