CARDINAL HEALTH SAN43ANEJDRecalls & reported problems
Cardinal Health 200, LLC · ANGIO PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888439280197), received between Feb 21, 2020 and Mar 16, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Adverse Event Without Identified Device or Use Problem1
- Material Fragmentation1
Patient problems
- Hemolysis1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2020Material Fragmentation
THE CUSTOMER REPORTED LINTING FROM THE BLUE SURGICAL TOWELS PWTB04-STM FROM THE HEARTH CATH PACK SAN23RCMWC DURING A LEFT HEART CATHETERIZATION. CUSTOMER STATED THE LINT WAS FOUND IN THE SALINE BOWL AND ON THE PROCEDURE TABLE, BUT COULD HAVE ENDED UP INSIDE THE PATIENT. REPORTEDLY, THERE WAS A DELAY OF APPROXIMATELY 15 MINUTE TO REMOVE ALL FLUIDS AND BLUE CARDINAL TOWELS IMMEDIATELY FROM PROCEDURE TABLE. THERE WAS NO INJURY TO THE PATIENT. CARDINAL HEALTH IS FILING A REPORT FOR POTENTIAL RISK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9837805 ↗InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED LINTING FROM THE BLUE SURGICAL TOWELS PWTB04-STM FROM THE ANGIOGRAPHY PACK SAN43ANEJD DURING A CARDIAC LEFT HEART ANGIOGRAM. PATIENT ENDED UP WITH A SEVERE HEMOLYSIS EPISODE. THE TOWELS WERE USED TO ABSORB FLUIDS IN THE FIELDS AND TOWELS WERE SATURATED WITH SALINE TO HELP IN THE ASSISTANCE OF HOLDING WIRES, CATHETERS, AND OTHER TOOLS IN PLACE. CUSTOMER REPORTED THERE WAS NO DELAY AS TOWELS WERE REMOVED WHEN LINTING WAS NOTICED. THERE WAS NO OTHER TYPE OF PATIENT INJURY REPORTED. MDR BEING FILED FOR RISK TO PATIENT.
Patient problems: Hemolysis
MAUDE report 9741817 ↗
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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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