St. Jude Medical Recalls Optisure Dual Coil Defibrillation Leads
St. Jude Medical is recalling Optisure Dual Coil Defibrillation Leads due to potential insulation cuts in the SVC shock coil.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as 'Class I', which mandates a severity score of 5 (Critical) per the rubric, as FDA Class I recalls indicate a reasonable probability of serious adverse health consequences or death.
Plain-English summary
St. Jude Medical Cardiac Rhythm Management Division is recalling Optisure Dual Coil Defibrillation Leads, including models LDA220, LDA220Q, LDA230Q, and LDP220Q. These leads are designed for long-term attachment to an Implantable Cardioverter Defibrillator (ICD).
The recall was initiated because the leads may have been compromised during the manufacturing process, specifically with cuts in the insulation layer of the SVC shock coil. A total of 447 units are affected, with 281 units distributed in the United States and the remainder distributed worldwide in Belgium, Switzerland, Germany, France, the United Kingdom, India, Italy, Japan, Luxembourg, The Netherlands, Saudi Arabia, and Sweden.
Patients with these specific leads should contact their healthcare provider for evaluation and potential replacement. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
Distribution
Distributed nationwide across the United States.
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