Recall Z-0593-2019 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
St. Jude Medical, Inc.
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 Us
| Date | Oct 11, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Mixed-up of materials/components |
| Action | On October 11, 2018, the firm sent an Urgent Medical Device Recall Notice to customers (i.e, Hospital Administrators) via overnight mail service informing them that the firm's records indicate that the institution has/had received the affected 8-Channel Lead that may be impacted by an isolated manufacturing issue. The notification explains that the firm believes that some of the listed leads may contain an electrode that does not conform to material specification. In total, there have been four (4) reports from (2) centers describing that the most proximal stimulation tip electrode (electrode |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.