Centurion SV353UDTRecalls & reported problems
Centurion Medical Products Corporation · SV SHIELD SYS., MED, ST, 3 3/4 x 5 7/16 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00653160224726), received between May 2, 2024 and May 2, 2024 — classified as 1 injury.
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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Anxiety1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, "I FOUND THE PIC LINE ON THE FLOOR AND THE DRESSING IS INTACT. THE EXTREMELY THIN TUBING OF THE DEVICE SLIPPED UNDER THIS UNSUITABLE DRESSING, THUS DEPRIVING THE PATIENT OF HER ANALGESICS, SEDATIVE, AND FOOD."
Patient problems: Anxiety; Pain
MAUDE report 19234514 ↗
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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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