CARDINAL HEALTH SANHFHCSBDRecalls & reported problems
Cardinal Health 200, LLC · HEART CATHETER 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 10888439335026), received between Jun 12, 2020 and Jun 19, 2020 — classified as 2 malfunctions.
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
- Product Quality Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2020Contamination /Decontamination Problem
CUSTOMER REPORTED THE PACK REPORTEDLY CONTAINED TOWELS WITH EXCESS LINT. ALLEGEDLY ON THE MOST RECENT OCCASION, THE PHYSICIAN WAS INTERVENING AND TOWEL LINT WAS FOUND ON THE INSTRUMENTS. NO INJURY WAS REPORTED. CARDINAL HEALTH IS FILING A REPORT FOR POTENTIAL RISK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10174980 ↗MalfunctionJun 12, 2020Product Quality Problem
BASED ON INFORMATION RECEIVED FROM THE CUSTOMER THE PACK REPORTEDLY CONTAINED TOWELS WITH EXCESS LINT. ALLEGEDLY ON THE MOST RECENT OCCASION, THE PHYSICIAN WAS INTERVENING, AND TOWEL LINT WAS FOUND INSIDE THE TUOHY NEEDLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10148911 ↗
Other Cardiac catheterization kit devices
- Medline Industries, Inc. DYNJ44700JMedline Industries, Inc. · Cardiac catheterization kit3 recalls1 report
- 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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