Medtronic Temporary Pacing Lead System Recalled for Design Non-Compliance
Medtronic is recalling Temporary Pacing Lead Systems because they do not meet design standards preventing connection to hazardous voltage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 hazard involves a risk of harm (hazardous voltage) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic Inc. is recalling the Temporary Pacing Lead System, Model 6416, Sterile EO. The recall involves 11,697 units distributed worldwide, including the United States and numerous international locations. The affected products are used for temporary intracardiac pacing and electrogram recording.
The recall was initiated because the device does not comply with Section 8.5.2.3 of IEC 60601-1 and corresponding provisions of FDA 21 CFR 898. These regulations relate to design standards intended to prevent connecting a patient's lead to a possible hazardous voltage. The agency classification for this recall is Class II.
Healthcare facilities and distributors should stop using the affected units and contact Medtronic for instructions on return or replacement. The recall covers all lots manufactured after May 1, 2014, as of May 23, 2016, with expiration dates through April 12, 2018.
The recalled product
- Product
- Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is…
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure
- Category
- Medical Device — Cardiac Pacing
Distribution
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