Cook Spectrum G43995Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002439955), received between Jul 3, 2018 and Mar 6, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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
- Component Missing1
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2019Fracture; Fracture
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8394528 ↗InjuryJul 3, 2018Component Missing; Component Missing
IT WAS REPORTED A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER SET WAS USED AS A CENTRAL LINE FOR POSTOPERATIVE MANAGEMENT. THE DEVICE WAS INSERTED AND OCCLUSIVE CLAMPS WERE FOUND MISSING. THE DEVICE WAS REMOVED AND A LIKE DEVICE WAS INSERTED UTILIZING A GUIDE WIRE IN AT THE SAME INSERTION SITE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 7657955 ↗
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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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