Medline Industries, Inc. DYNJ49357ARecalls & reported problems
Medline Industries, Inc. · NEURO PACK · Class 1
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 10889942564521), received between Feb 23, 2018 and Feb 23, 2018.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
Feb 23, 2018Device Contamination with Chemical or Other Material
PT WAS IN INTERVENTIONAL RADIOLOGY (IR) FOR A STROKE THROMBECTOMY. DURING THE FINAL PASS OF THE DEVICE, WHEN THE MD PULLED THE STENT RETRIEVER OUT, THE TEAM NOTICED A "BLUE" ITEM WITHIN THE BASKET OF THE DEVICE. THIS "BLUE" ITEM WAS NOT NOTICED ON ANY PRIOR USES OF THE DEVICE. THE DEVICE AND OTHER CATHETERS ON THE TABLE WERE COLLECTED AND PLACED INTO A BIOHAZARD BAG. THE ITEM APPEARS TO BE BLUE LINT FROM THE TOWELS IN THE KIT. MEDLINE, US.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7295987 ↗
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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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