Centurion Medical Recalls LVAD Kits Due to Incomplete Sterile Seals
Centurion Medical Products Corporation is recalling various LVAD maintenance kits because incomplete seals on the sterile packages 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 potential compromise of sterility without confirmed illness.
Plain-English summary
Centurion Medical Products Corporation is recalling multiple lots of Centurion-Drive Kits, including daily LVAD maintenance kits, driveline management systems, and dressing systems. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the medical devices.
The affected products were distributed nationwide and to Ghana. The recall includes specific lots of products such as the DM1005 Daily LVAD Maintenance Kit, DM280A LVAD Management System, and DM320 Percutaneous Lead Management Kit, among others. The source text does not specify the total number of units affected or the exact dates of distribution.
Patients using these devices should contact their healthcare provider or Centurion Medical Products Corporation for further instructions on how to proceed. The company is responsible for the recall and will provide guidance on the next steps for affected users.
The recalled product
- Product
- Centurion-Drive 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…
- Manufacturer
- Centurion Medical Products Corporation
- 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
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Similar recalls
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