Halyard 77748Recalls & reported problems
O&M Halyard, Inc. · CARDIOVASCULAR PACK II · Class 2
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 10680651777482), received between Apr 21, 2025 and Apr 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Misconnection1
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.
MalfunctionApr 21, 2025Misconnection; Detachment of Device or Device Component; Misconnection; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE USING A CARDIOVASCULAR PACK, THE BAG OF THE INCISE SHEET TORE OFF AND MEDICAL INSTRUMENTS FELL TO THE FLOOR. THE CUSTOMER BELIEVES THIS WAS AN ISSUE WITH THE ADHESION OF THE POCKETS. THE CUSTOMER ATTACHED THE BAG USING OTHER DEVICES. THIS OCCURRED DURING A CARDIOVASCULAR PROCEDURE. THERE WAS A 30-MINUTE SURGICAL DELAY IN PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21878257 ↗
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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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