St — Class II medical device recall Z-0593-2019
Terminated recall by St. Jude Medical, Inc., reported 2018-12-19, distributed nationwide. The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N ins
| Recall number | Z-0593-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Inc., Plano, TX, United States |
| Recall initiated | 2018-10-11 |
| Classified | 2018-12-10 |
| Reported by FDA | 2018-12-19 |
| Terminated | 2022-09-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CO, CZ, DE, ES, FI, FR, GB, HU, IT, KR, MX, PL, SA, SE, TR, TW |
| UPC / GTIN / UDI-DI | 05415067020635, 05415067020680, 05415067030306, 05415067030320 |
| Lot numbers | 17078868, 17078872, 17078875, 17078876, 17078878, 17078880, 17078882, 17078883, 17078885, 17078886, 17078887, 17078888, 17078889, 17078891, 17078892, 17078893, 17078894, 17078899, 17078901, 17078906, 17078907, 17078909, 17078910, 17078912, 17078921, 17078924, 17078925, 17078926, 17078927, 17078928, 17078934, 17086331, 17086332, 17086333, 17086334, 17086335, 17086336, 17086337, 17086338, 17086339 and 460 more |
| Serial numbers | 17078868, 17078872, 17078875, 17078876, 17078878, 17078880, 17078882, 17078883, 17078885, 17078886, 17078887, 17078888, 17078889, 17078891, 17078892, 17078893, 17078894, 17078899, 17078901, 17078906, 17078907, 17078909, 17078910, 17078912, 17078921 and 475 more |
| Model numbers | 6170, 6170ANS, 6172, 6172ANS |
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 for recall
The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0593-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.