St Jude Medical recalls Infinity DBS System 8CH Directional Leads with possible MP35N instead of 90/10 platinum-iridium. Affected units have specific serial numbers. Contact for remedy.
The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium.
St. Jude Medical is recalling certain Infinity DBS System 8CH Directional Leads that may contain MP35N material instead of the required 90/10 platinum-iridium. This could affect the safety of the device if used in brain stimulation procedures. The recall includes specific model numbers and serial numbers.
The hazard involves the electrode material being incorrect. The leads are designed for brain stimulation surgery and must use 90/10 platinum-iridium to ensure proper function and safety. If the material is MP35N instead, it may not perform as intended and could lead to complications.
Patients with deep brain stimulation implants using these leads are most at risk. The recall affects specific model numbers and serial numbers listed in the notice.
Check for the model numbers 6170ANS or 6172ANS with specific serial numbers listed in the recall notice. The leads are used in deep brain stimulation systems.
Look for the serial numbers listed in the recall notice to determine if your device is affected.
The recalled leads are model 6170ANS and 6172ANS.
The leads may contain MP35N instead of the required 90/10 platinum-iridium.
Check the serial numbers listed in the recall notice; affected units have specific serial numbers provided.
We’ve drafted a message you can send St Jude Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0593-2019 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-0593-2019 from St Jude Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
