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.
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 2/5 (Moderate).
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…
- 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.
Related recalls
Same manufacturer · Medtronic Inc. Cardiac Rhythm Disease Management
See all →- ModerateMedtronic SureScan Pacemaker ID Cards Mislabel MR Conditional Status
FDA (Devices) · 2015-10-14
- HighMedtronic CryoConsole Recalled Due to USB Component Issue
FDA (Devices) · 2015-09-23
- SevereMedtronic Temporary Pacemaker Recalled for Battery Connection Failure
FDA (Devices) · 2015-04-08
- ModerateMedtronic Recalls Trellis 6 and 8 Peripheral Infusion Systems for Sterility Breach
FDA (Devices) · 2015-04-08
- SevereMedtronic FlexCath Select Steerable Sheath Recalled for Valve Debris
FDA (Devices) · 2015-03-25
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateMedtronic Launcher Coronary Guide Catheter Recalled for Incorrect Length
FDA (Devices) · 2014-11-19
- SevereMedtronic Guide Catheter Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2021-03-17
- SevereMedtronic Guide Catheter Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-03-17
- ModerateMedtronic Mullins Transseptal Catheter Sheath Recall for Labeling Error
FDA (Devices) · 2013-08-14
- HighMedtronic 6F Launcher Guide Catheter Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-03-17
- LowMedtronic DxTerity Diagnostic Catheter Recalled for Incorrect Box Labeling
FDA (Devices) · 2018-05-02