Centurion DM1285ARecalls & reported problems
Centurion Medical Products Corporation · LVAD KIT · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653160367543), received between Sep 30, 2026 and Sep 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Misassembled” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Component Misassembled1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Component Misassembled
It was reported that "The gloves were included on the outside of the kit, thus compromising the sterility."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945864 ↗
Other TRAY, SURGICAL devices
- MEDLINE DYNDA2526Medline Industries, Inc. · TRAY, SURGICAL3 recalls0 reports
- MEDLINE DYNDH1534Medline Industries, Inc. · TRAY, SURGICAL3 recalls0 reports
- MEDLINE DYNDH1470BMedline Industries, Inc. · TRAY, SURGICAL3 recalls0 reports
- Centurion MNS11625Centurion Medical Products Corporation · TRAY, SURGICAL3 recalls0 reports
- MEDLINE DYKM1756AMedline Industries, Inc. · TRAY, SURGICAL2 recalls0 reports
- MEDLINE SPEC0291BMedline Industries, Inc. · TRAY, SURGICAL2 recalls0 reports
- MEDLINE DYNDC3188Medline Industries, Inc. · TRAY, SURGICAL2 recalls0 reports
- MEDLINE DYNDH1542Medline Industries, Inc. · TRAY, SURGICAL2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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