Cook G00060Recalls & reported problems
Cook Incorporated · Connecting Tube Female to Male Luer Lock · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002000605), received between Apr 30, 2018 and Dec 2, 2020 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 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 16, 2026.
Most reported problems
Device problems
- Leak/Splash4
- Fluid/Blood Leak2
- Material Integrity Problem1
Patient problems
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2020Leak/Splash; Leak/Splash
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10936318 ↗MalfunctionAug 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION WAS RECEIVED. CONTRAST LEAKED FROM THE DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10413575 ↗MalfunctionJul 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8816644 ↗MalfunctionDec 11, 2018Material Integrity Problem; Material Integrity Problem
PLEASE SEE H10 FOR ADDITIONAL INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8151089 ↗MalfunctionApr 30, 2018Leak/Splash
THE COMPLAINANT REPORTED CONTRAST MEDIA LEAKAGE WHEN USING THE HIGH PRESSURE BRAIDED CONNECTING TUBE (INJECT GUN SETTING 1000PSI, REAL INJECT 890PSI). THIS PRODUCT PROBLEM OCCURRED PRIOR TO PATIENT CONTACT FOR A TACE (TRANSARTERIAL CHEMOEMBOLIZATION) PROCEDURE IN THE LIVER. THERE WAS NO REPORTED IMPACT TO THE PATIENT AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7474164 ↗MalfunctionApr 30, 2018Leak/Splash
THE COMPLAINANT REPORTED CONTRAST MEDIA LEAKAGE WHEN USING THE HIGH PRESSURE BRAIDED CONNECTING TUBE (INJECT GUN SETTING 1000PSI, REAL INJECT 890PSI). THIS PRODUCT PROBLEM OCCURRED PRIOR TO PATIENT CONTACT FOR A TACE (TRANSARTERIAL CHEMOEMBOLIZATION) PROCEDURE IN THE LIVER. THERE WAS NO REPORTED IMPACT TO THE PATIENT AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7474129 ↗MalfunctionApr 30, 2018Leak/Splash
THE COMPLAINANT REPORTED CONTRAST MEDIA LEAKAGE WHEN USING THE HIGH PRESSURE BRAIDED CONNECTING TUBE (INJECT GUN SETTING 1000PSI, REAL INJECT 890PSI). THIS PRODUCT PROBLEM OCCURRED PRIOR TO PATIENT CONTACT FOR A TACE (TRANSARTERIAL CHEMOEMBOLIZATION) PROCEDURE IN THE LIVER. THERE WAS NO REPORTED IMPACT TO THE PATIENT AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7474058 ↗
Other Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices
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- Copilot 1003331Abbott Vascular Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass189 reports
- DLP® 11001GMedtronic, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass2 recalls0 reports
- RHV 23242Abbott Vascular Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass66 reports
- DLP® 14000Medtronic, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall2 reports
- PhD™ 00884450746745Merit Medical Systems, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall2 reports
- PhD™ 00884450746714Merit Medical Systems, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall1 report
- NAMIC 64038301Medline Industries, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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