Halyard PSSC004-03_0001Recalls & reported problems
Avid Medical, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
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
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10809160348895), received between Feb 21, 2025 and Feb 24, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Contamination” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Sep 20, 2024Class IIOpen, Classified
Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
Z-0422-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Contamination2
Patient problems
- Unspecified Infection2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2025Contamination; Contamination
INCIDENT ONE: PATIENT WAS REPORTED TO HAVE A POST-SURGICAL INFECTION. THERE WAS MEDICAL INTERVENTION (ANTIBIOTICS) PROVIDED FOR THIS PATIENT WHICH REQUIRED A PROLONG HOSPITAL STAY DUE TO COMPLICATIONS FROM INFECTION. AN ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED ON FEBRUARY 6, 2025, FEBRUARY 11, 2025, AND FEBRUARY 17, 2025, AT THIS TIME THE SITE IS AWAITING FURTHER INFORMATION ABOUT THE INFECTION, TYPE OF PROCEDURE, AND TECHNIQUE PERFORMED BY THE HOSPITAL.
Patient problems: Unspecified Infection
MAUDE report 21453830 ↗InjuryFeb 21, 2025Contamination; Contamination
INCIDENT TWO: PATIENT WAS REPORTED TO HAVE A POST-SURGICAL INFECTION. THERE WAS MEDICAL INTERVENTION (ANTIBIOTICS) PROVIDED FOR THIS PATIENT. ADDITIONAL INFORMATION WAS REQUESTED ON FEBRUARY 6, 2025, FEBRUARY 11, 2025, AND FEBRUARY 17, 2025, THE SITE IS CURRENTLY AWAITING FURTHER DETAILS INCLUDING DETAILS OF THE TYPE OF INFECTION, TYPE OF PROCEDURE, AND TECHNIQUE UTILIZED BY THE CUSTOMER.
Patient problems: Unspecified Infection
MAUDE report 21436894 ↗
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- Medline Industries, Inc. ECVC6505Centurion Medical Products Corporation · Cardiac catheterization kit3 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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