Cook Spectrum G35136Recalls & reported problems
Cook Incorporated · Spectrum, Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter · Class 2
All models of Cook Spectrum (67)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002351363), received between Jun 21, 2024 and Jun 26, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Crack” (3 reports).
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
- Crack3
Patient problems
- Insufficient Information2
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2024Crack; Crack
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 19616761 ↗InjuryJun 25, 2024Crack; Crack
IT WAS REPORTED THAT THE BLUE HUB OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY CRACKED. THE DEVICE WAS PLACED IN THE PATIENT'S LEFT INTERNAL JUGULAR ON (B)(6) 2024. ALCOHOL SWABS WERE USED TO CLEAN THE HUBS DURING NEEDLELESS CAP PLACEMENT AND FOR HUB ACCESS. ON (B)(6) 2024, THE PATIENT HAD BLOOD PRESSURE MEDICATION INFUSING THROUGH THE BLUE LUMEN WHEN A SUDDEN DROP IN BLOOD PRESSURE WAS OBSERVED. ADDITIONALLY, IT WAS NOTED THE BED LINEN WAS WET. AT THIS TIME, THE CRACK IN THE BLUE HUB WAS DISCOVERED. THE INFUSION WAS MOVED TO A DIFFERENT LUMEN, AND THE BLOOD PRESSURE STABILIZED. THEN, THE DEVICE WAS REMOVED AND REPLACED. THE CUSTOMER NOTED THEY DO NOT BELIEVE THE NEEDLELESS ENDCAPS ARE BEING OVERTIGHTENED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 19609760 ↗InjuryJun 21, 2024Crack; Crack
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 19588789 ↗
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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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