FDA Device recall Z-0593-2019
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,…
- FDA Device
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of 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,… by St Jude Medical, citing the most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0593-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-11 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | St Jude Medical |
| Distribution | US |
Product
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.
Reason
The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium.
Identifiers
| code_info | For Model 6170ANS: UDI/GTIN - 05415067020635 / 05415067030306 US: Serial Numbers Lot Number 17277045…For Model 6170ANS: UDI/GTIN - 05415067020635 / 05415067030306 US: Serial Numbers Lot Number 17277045 6351121 OUS: 17145460 6244627 17149644 6262443 17149652 6262443 17149625 6262443 17149630 6262443 17149631 6262443 17149647 6262443 17149650 6262443 17149653 6262443 17168532 6272675 17168533 6272675 17168534 6272675 17168541 6272675 17145439 6244627 17145459 6244627 17145461 6244627 17145463 6244627 17113441 6212647 17113442 6212647 17113445 6212647 17145451 6244627 17113436 6212647 17145454 6244627 17145458 6244627 17145438 6244627 17145446 6244627 17145448 6244627 17145453 6244627 17145457 6244627 17145462 6244627 17166635 6272679 17113438 6212647 17149635 6262443 17149641 6262443 17149655 6262443 17166627 6272679 17149629 6262443 17149633 6262443 17149637 6262443 17149645 6262443 17149646 6262443 17149626 6262443 17149654 6262443 17145447 6244627 17145456 6244627 17215431 6299732 17215434 6299732 17215455 6299732 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0593-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.