Cook Spectrum G43983Recalls & reported problems
Cook Incorporated · Spectrum, Central Venous Catheter Set Minocycline/Rifampin Antibiotic Impregnated Double Lumen Polyurethane · Class 2 · Implant
All models of Cook Spectrum (67)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002439832), received between Sep 20, 2018 and Sep 20, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Obstruction of Flow” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Recalls naming this device
- Mar 5, 2026Open, Classified
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1788-2026 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗
Most reported problems
Device problems
- Obstruction of Flow1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 20, 2018Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER WAS FOUND TO BE OCCLUDED. THE DEVICE WAS REMOVED AND DISCARDED AND A LIKE DEVICE FROM THE SAME LOT WAS PLACED IN THE RIGHT FEMORAL VEIN. THIS DEVICE WAS FOUND TO BE OCCLUDED AFTER INSERTION AND WAS REMOVED. A THIRD DEVICE FROM THE SAME LOT WAS PLACED IN THE LEFT FEMORAL VEIN WITH NO INCIDENT TO COMPLETE THE PROCEDURE SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE AND IS IN STABLE CONDITION.
Patient problems: No Code Available
MAUDE report 7894518 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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