St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086…
Medical device recall Z-0593-2019. Published in FDA’s Enforcement Report on Dec 19, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 19, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 16 states named
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,993 characters
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 17113440 6212647 17113447 6212647 17149624 6262443 17149640 6262443 17166633 6272679 17149634 6262443 17215427 6299732 17215438 6299732 17215440 6299732 17215444 6299732 17145441 6244627 17145444 6244627 17149628 6262443 17149649 6262443 17166624 6272679 17166631 6272679 17166634 6272679 17166640 6272679 17166623 6272679 17149642 6262443 17149658 6262443 17166625 6272679 17166629 6272679 17166638 6272679 17166641 6272679 17168535 6272675 17233826 6320021 17233834 6320021 17233846 6320021 17233856 6320021 17168524 6272675 17168525 6272675 17168526 6272675 17168529 6272675 17168531 6272675 17168538 6272675 17168543 6272675 17168545 6272675 17168547 6272675 17168528 6272675 17168537 6272675 17168546 6272675 17168548 6272675 17233830 6320021 17233838 6320021 17233848 6320021 17233850 6320021 17233854 6320021 17233855 6320021 17145437 6244627 17233835 6320021 17168521 6272675 17113434 6212647 17149638 6262443 17166622 6272679 17145440 6244627 17145455 6244627 17149632 6262443 17215428 6299732 17215429 6299732 17215433 6299732 17215435 6299732 17215437…
FDA’s list runs to 21,307 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
The states and territories these words name
16 states and territories.
Every one of them
- Arizona
- California
- Colorado
- Florida
- Georgia
- Illinois
- Maryland
- Minnesota
- Missouri
- Montana
- North Carolina
- New Jersey
- New York
- Ohio
- Pennsylvania
- Washington
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 11, 2018.
- FDA classified it on Dec 10, 2018.
- FDA’s Enforcement Report published it on Dec 19, 2018.
- FDA terminated it on Sep 13, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- St. Jude Medical, Inc., of Plano, TX.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 21,307 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.