Medtronic Launcher Guiding Catheter Recalled for Labeling Errors
Medtronic is recalling 24 units of Launcher Guiding Catheters because the packaging labels do not accurately reflect the catheters inside.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error that does not explicitly report injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Medtronic Inc. Cardiac Rhythm Disease Management is recalling 24 units of the Launcher Guiding Catheter. The affected products include Model # LA8EBU45SH (Lot # 0006722866, 8F) and Model # LA6IMAD (Lot # 0006724224, 6F). These devices are designed to provide a pathway for therapeutic devices in the coronary or peripheral vascular system.
The recall was initiated because the two affected catheter lots are mislabeled. The labels on the packages do not accurately reflect the specific catheters contained within them. This labeling issue could lead to the use of an incorrect device size or type during a procedure.
The 24 affected units were distributed internationally to Germany and Poland. Healthcare providers and facilities that have received these specific lots should stop using them and contact Medtronic for instructions on how to return the devices.
The recalled product
- Product
- Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is i
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model # LA8EBU45SH
- Lot # 0006722866 and Model # LA6IMAD
- Lot # 0006724224.
Distribution
Distribution scope not specified by the agency.
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