St. Jude Medical DBS Leads Recalled for Incorrect Electrode Material
St. Jude Medical is recalling Deep Brain Stimulation leads where the most proximal unsegmented electrode may be made of MP35N instead of the required 90/10 platinum-iridium.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or deaths. Per the rubric, a Class II recall without reported hospitalizations or injuries falls under 'High' severity (risk-of-harm products where injury has not yet been reported).
Plain-English summary
St. Jude Medical, Inc. is recalling specific models of the Infinity DBS System 8CH Directional Leads (30 cm and 40 cm) due to a material defect. The most proximal unsegmented electrode of these leads may have been constructed with MP35N instead of the required 90/10 platinum-iridium alloy specified in the product drawings.
The affected products are distributed worldwide, including in the United States and various international markets. The recall covers specific serial and lot numbers for Model 6170ANS and Model 6172ANS. These leads are intended to deliver electrical stimulation to target areas in the brain and are implanted using standard stereotactic neurosurgical techniques.
Patients with these implanted leads should contact their healthcare provider or St. Jude Medical for further instructions. The manufacturer is working to identify and address the units affected by this material deviation.
The recalled product
- 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
- Manufacturer
- St. Jude Medical, Inc.
- Hazard
Distribution
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