Medline Industries, Inc. DYNJ41133DRecalls & reported problems
Medline Industries, Inc. · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10198459249662), received between Aug 12, 2025 and Aug 12, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Crack” (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.
Reports received per month
Most reported problems
Device problems
- Crack1
Patient problems
- Air Embolism1
- Altered State of Consciousness1
- Arrhythmia1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2025Crack; Crack
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 AN "AIR EMBOLISM" WAS IDENTIFIED "ON FLUOROSCOPY" DURING A "LEFT HEART CATH PROCEDURE" WHICH CAUSED THE PATIENT TO BECOME "UNRESPONSIVE, HYPOTENSIVE, AND HAVE ST CHANGES".
Patient problems: Air Embolism; Altered State of Consciousness; Arrhythmia; Low Blood Pressure/ Hypotension
MAUDE report 22784897 ↗
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- 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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