Reported Dec 19, 2018 · Terminated
St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St.…
St. Jude Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St. Jude Medical, Inc. · 6901 Preston Rd · Plano, TX · 75024-2508
Is this the product you have?
- 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 UseLead and Extension Kits for Deep Brain Stimulation Systems Clinician's Manual ST
- JUDE MEDICAL - Product UsageSt. 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
- Lot codes and dates
- For Model 6170ANSUDI/GTIN - 05415067020635 / 05415067030306
- USSerial
- Numbers Lot Number 17277045 6351121 OUS
614 of 614 codes
171454606244627171496446262443171496526262443171496256262443171496306262443171496316262443171496476262443171496506262443171496536262443171685326272675171685336272675171685346272675171685416272675171454396244627171454596244627171454616244627171454636244627171134416212647171134426212647171134456212647171454516244627171134366212647171454546244627171454586244627171454386244627171454466244627171454486244627171454536244627171454576244627171454626244627
- For Model 6172ANSUDI/GTIN - 05415067020680 / 05415067030320
- USSerial Numbers Lot Number
1,054 of 1,054 codes
171012686212648171012716212648171012796212648171012816212648171012826212648171012856212648171012886212648171012926212648171012946212648171012976212648171012986212648171013016212648171013026212648171013156212648171013166212648171013186212648171013226212648171013076212648171012966212648171012936212648171013046212648171455616244642171455396244642171455426244642171455496244642171580246262459171580166262459171580296262459171747756272706171747656272706
- OUS
814 of 814 codes
171037716212651171037746212651171037786212651171037816212651171037856212651171037876212651171037896212651170863436197963170863486197963170863366197963170863386197963170863396197963170863406197963170863516197963170863526197963171037766212651171454866244631171454926244631171454826244631171454836244631171454946244631171454966244631171740876272696171740886272696171740896272696171740906272696171740916272696171740926272696171740936272696171740946272696
- Amount recalled
- N/A
Where it was sold
Why it 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.
This product could cause temporary or reversible health problems — stop using it.
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