CARDINAL HEALTH SANHFCCMHFRecalls & reported problems
Cardinal Health 200, LLC · CARDIAC CATH PACK · Class 2
Data updated Oct 18, 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 10888439826364), received between Apr 1, 2021 and Apr 1, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Frayed” (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 18, 2026.
Most reported problems
Device problems
- Material Frayed1
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 1, 2021Material Frayed; Material Frayed
CUSTOMER REPORTED OPERATING ROOM TOWELS (PWTB04-STM ) ARE LINTING ON INSTRUMENTS AND CAME IN THE AIR WHEN PACK(SANHFCCMHF) WAS OPENED BEFORE PERIPHERAL PROCEDURE. THE TOWELS WERE REMOVED UPON FINDING LINT AND WAS DISCARDED. THERE WERE NO DELAYS OR INJURY NOTED. NO PATIENT DEMOGRAPHICS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11606330 ↗
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- Merit Medical® 00884450140840Merit Medical Systems, Inc. · Angiography/angioplasty kit2 recalls0 reports
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- Medline Industries, Inc. DYNJ63542BMedline Industries, Inc. · Angiography/angioplasty kit2 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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