CARDINAL HEALTH SCV23IRCHARecalls & reported problems
Cardinal Health 200, LLC · STERILE IR AORTAGRAM 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 10887488708577), received between Mar 11, 2019 and Mar 11, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
- Contamination /Decontamination Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2019Contamination /Decontamination Problem
THE CUSTOMER REPORTED THAT THE BLUE OPERATING ROOM TOWELS PWTB03-STMA FROM THE INTERVENTIONAL RADIOLOGY AORTAGRAM PACK/SCV23IRCHA WERE LINTING AND THEIR GLOVES RETAINED THE LINT. THE TOWELS WERE USED TO SOAK UP BLOOD AND NORMAL SALINE. THERE WAS NO INJURY. NEW GLOVES AND NORMAL SALINE WERE OBTAINED AND USED TO COMPLETE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8410077 ↗
Other Angiography/angioplasty kit devices
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- Merit Medical® 00884450255803Merit Medical Systems, Inc. · Angiography/angioplasty kit3 recalls0 reports
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- Medline Industries, Inc. DYNJ0842873JMedline Industries, Inc. · Angiography/angioplasty kit3 recalls0 reports
- 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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