Medline Industries, Inc. DYNJ83291Recalls & reported problems
Medline Industries, Inc. · CARDIAC CATH 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 10195327258405), received between Dec 18, 2025 and Dec 18, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2025Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE SYRINGE HAD NO OPENING. THE SYRINGE WAS BEING USED TO DRAW HEPARINIZED SALINE FROM A BOWL DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SYRINGE WITH ADDITIONAL SYRINGES FROM STOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23842860 ↗MalfunctionDec 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON (B)(6) 2025 WHEN ATTEMPTING TO UTILIZE THE SYRINGE TO "PULL HEP SALINE OUT OF BOWL", IT WAS DISCOVERED THAT THE SYRINGE HAD "NO OPENING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23838450 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page