CARDINAL HEALTH SAN47BS797Recalls & 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 10888439184075), received between Jan 31, 2019 and Jan 31, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2019Physical Resistance/Sticking
THE CUSTOMER REPORTED THAT LINT FROM THE BLUE OR TOWELS PWTB04-STM FROM CATALOG SAN47BS797, CARDIAC CATHETER PACK WAS NOTICED ON THE STERILE FIELD AND STICKING TO A CORONARY CATHETER DURING A LEFT HEART ANGIOGRAM PROCEDURE BY THE DOCTOR. DOCTOR RINSED OFF THE CATHETER WITH SALINE AND CONTINUED ON WITH THE CASE. THERE WAS NO INJURY. NO PATIENT DEMOGRAPHICS WERE PROVIDED. THE ACTUAL DATE OF THE COMPLAINT IS UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8294895 ↗
Other Cardiac catheterization kit devices
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- Medline Industries, Inc. ECVC2555Centurion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. DYNJ83089Medline Industries, Inc. · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. DYNJ0578916XMedline Industries, Inc. · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. MNS9935Medline Industries, Inc. · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. ECVC5540ACenturion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. ECVC2745Centurion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. ECVC6505Centurion Medical Products Corporation · Cardiac catheterization kit3 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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