Centurion DM100Recalls & reported problems
Centurion Medical Products Corporation · WEEKLY LVAD TRAY · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10653160280101), received between Sep 2, 2026 and Sep 10, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Degraded” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Mar 16, 2026Open, Classified
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Z-2045-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Degraded2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Degraded
It was reported that "We had a customer receive some DM100 kits with dry sorbaview that would not stick." "All 24 kits received were impacted."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713809 ↗MalfunctionSep 2, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566304 ↗
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- Centurion DM1035ACenturion Medical Products Corporation · Dressing change tray2 recalls0 reports
- Centurion DM1035Centurion Medical Products Corporation · Dressing change tray2 recalls0 reports
- MEDLINE EBSI1498Medline Industries, Inc. · Dressing change tray2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.