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
Check against the official notice below — it lists the full affected range.
St. Jude Medical is recalling the InfinityTM DBS System 8CH Directional Lead, 30 cm, model 6170. The most proximal unsegmented electrode on these Deep Brain Stimulation leads may have been made from MP35N material instead of the required 90/10 platinum-iridium. The affected devices were distributed worldwide, including nationwide distribution across multiple U.S. states and international distribution to numerous countries.
The recall affects specific serial numbers and lot numbers for model 6170ANS. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 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. Distribution: 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 Un Quantity: N/A Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.