SELF CENTERING 2055-11-000Recalls & reported problems
Depuy (Ireland) · SELF CENTERING MODULAR CATHCART HEMI HEAD INSTRUMENT TRAY · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295084419), received between Mar 4, 2026 and May 8, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (4 reports).
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
Most reported problems
Device problems
- Peeled/Delaminated4
- Break2
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Break; Crack; Peeled/Delaminated
IT WAS REPORTED THAT THE METAL IS DELAMINATING FROM PLASTIC, THE PLASTIC LIDS ARE BROKEN. THE PLASTIC IS CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122615 ↗MalfunctionMay 8, 2026Break; Crack; Peeled/Delaminated
IT WAS REPORTED THAT THE METAL IS DELAMINATING FROM PLASTIC, THE PLASTIC LIDS ARE BROKEN. THE PLASTIC IS CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122613 ↗MalfunctionMar 4, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS PEELING WOULD NOT STERILIZE. THE EVENT DID NOT HAPPEN IN SURGERY. (B)(4) IS RELATED TO (B)(4) IS CREATED TO CAPTURE ADDITIONAL IPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24511246 ↗MalfunctionMar 4, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS PEELING WOULD NOT STERILIZE. THE EVENT DID NOT HAPPEN IN SURGERY. (B)(4) IS RELATED TO (B)(4) IS CREATED TO CAPTURE ADDITIONAL IPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24511030 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.