Centurion Medical Recalls LVAD Kits Due to Incomplete Sterile Package Seals
Centurion Medical Products Corporation is recalling various LVAD kits because incomplete seals on the sterile package may compromise sterility.
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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of Centurion-LVAD Kits, including daily maintenance kits, driveline management systems, and dressing systems. The recall is due to incomplete seals on the sterile package, which may compromise the sterility of the products.
The affected products were distributed nationwide and to Ghana. The source text does not specify the total number of units recalled or report any illnesses or injuries associated with the defect.
Consumers should stop using the affected kits and contact Centurion Medical Products Corporation for further instructions or a replacement.
The recalled product
- Product
- Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7 DM320 PERCUTANEOUS LEAD MANAGEMENT KIT DM380 DAILY LVAD KIT MORRISTOWN MEDICAL DM405A ADVOCATE CHRIST DAILY WET KIT DM405A ADVOCATE CHRIST DAILY WET KIT DM525 LVAD SENSITIVE KIT DM545…
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — LVAD Kits
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 recalled by Centurion Medical Products Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 54 products in this recall →Related recalls
Same manufacturer · Centurion Medical Products Corporation
See all →- HighCenturion Difficult IV Kit Recalled for False Carboxyhemoglobin Results
FDA (Devices) · 2020-07-15
- HighCenturion ENT Snuffer Kit Recalled for Incomplete Sterile Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Chest Tube Trays Recalled for Incomplete Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Pitcher Kits Due to Seal Defects
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Hyperalimentation and Dressing Change Trays
FDA (Devices) · 2020-02-12
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighCenturion Medical Recalls LVAD Dressing Kits Due to Sterile Packaging Concerns
FDA (Devices) · 2019-08-14
- CriticalCenturion LVAD Maintenance Kits Recalled for Potential Sterility Failure
FDA (Devices) · 2024-03-06
- HighCenturion Universal Line Full Body Drape Kit Recalled for Packaging Defect
FDA (Devices) · 2019-11-13
- SevereCenturion Medical Recalls High Drainage LVAD Tray Kits Due to Packaging Concerns
FDA (Devices) · 2019-08-14
- ModerateCenturion Driveline Management System 1 Daily Kit Recalled for Packaging Risk
FDA (Devices) · 2019-08-14
- HighCenturion Medical Recalls Daily Driveline Kits Due to Sterile Packaging Concerns
FDA (Devices) · 2019-08-14