Cook Spectrum G34914Recalls & 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
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 00827002349148), received between Jan 19, 2024 and Jan 19, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Crack” (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 18, 2026.
Reports received per month
Recalls naming this device
- Mar 5, 2026Class IIOpen, Classified
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1783-2026 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗
Most reported problems
Device problems
- Crack1
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 19, 2024Crack; Fluid/Blood Leak; Leak/Splash; Crack; Fluid/Blood Leak; Leak/Splash
IT WAS REPORTED THAT A CATHETER FROM A COOK¿S SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY LEAKED. THE DEVICE WAS PLACED IN THE PATIENT ON (B)(6) 2024. ON (B)(6) 2024, LEAKAGE AT THE HUB CONNECTION WAS DISCOVERED. THE COMPLAINT DEVICE WAS THEN REMOVED AND REPLACED. THE PATIENT EXPERIENCED A DECREASED BLOOD PRESSURE UNTIL THE DEVICE WAS REPLACED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 18546472 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page