Medline Industries, Inc. DYNJ44932NRecalls & reported problems
Medline Industries, Inc. · CV BYPASS PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10193489911060), received between Dec 12, 2022 and Mar 22, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Human-Device Interface 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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
- Human-Device Interface Problem1
Patient problems
- Foreign Body In Patient2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2024Human-Device Interface Problem; Human-Device Interface Problem
BULB SYRINGE IS DIFFICULT TO SQUEEZE.
Patient problems: Insufficient Information
MAUDE report 18961775 ↗InjuryDec 12, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, ON (B)(6) 2022 WHEN USING THE 'HALL SAW IN THE OR THE BLADE BROKE WHEN TRYING TO USE IT TO OPEN THE CHEST'.
Patient problems: Foreign Body In Patient
MAUDE report 15959195 ↗InjuryDec 12, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, ON (B)(6) 2022 WHEN USING THE 'HALL SAW IN THE OR THE BLADE BROKE WHEN TRYING TO USE IT TO OPEN THE CHEST'.
Patient problems: Foreign Body In Patient
MAUDE report 15958993 ↗
Other Cardiovascular procedure kit devices
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- Medline Industries, Inc. DYNJ0376608OMedline Industries, Inc. · Cardiovascular procedure kit4 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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