CARDINAL HEALTH SAN13AN60DRecalls & reported problems
Cardinal Health 200, LLC · ANGIOGRAPHY PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888439684230), received between Oct 7, 2020 and Oct 8, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
- Material Fragmentation1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2020Device Contamination with Chemical or Other Material
BASED ON INFORMATION FROM THE CUSTOMER THE BLUE TOWEL IS LAID ON THE DRAPE TO ABSORB FLUIDS, REPORTEDLY IF YOU TOUCH IT, SMALL PIECES COME OFF ON YOUR HANDS OR EQUIPMENT.
Patient problems: Insufficient Information
MAUDE report 10648570 ↗MalfunctionOct 7, 2020Material Fragmentation
BASED ON INFORMATION FROM THE CUSTOMER THE BLUE TOWEL IS LAID ON THE DRAPE TO ABSORB FLUIDS, REPORTEDLY IF YOU TOUCH IT, SMALL PIECES COME OFF ON YOUR HANDS OR EQUIPMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10642341 ↗
Other Angiography/angioplasty kit devices
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- Medline Industries, Inc. DYNJ40632CMedline Industries, Inc. · Angiography/angioplasty kit2 recalls1 report
- Merit Medical® 00884450140840Merit Medical Systems, Inc. · Angiography/angioplasty kit2 recalls0 reports
- Merit Medical® 00884450140796Merit Medical Systems, Inc. · Angiography/angioplasty kit2 recalls0 reports
- 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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