Cook G01916Recalls & reported problems
Cook Incorporated · Central Venous Catheter Set · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002019164), received between Jun 11, 2018 and Jun 12, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (2 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
- Crack2
- Kinked1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2018Crack; Kinked
IT WAS REPORTED THAT FOUR HOURS AFTER PLACEMENT OF THE SINGLE LUMEN PRESSURE MONITORING SET IN THE RIGHT FEMORAL ARTERY, THE ARTERIAL LINE WAVEFORM WAS FOUND TO BE FLAT. THE CATHETER WAS REMOVED AND FOUND TO BE KINKED AND CRACKED ON BOTH SIDES APPROXIMATELY 2.25CM FROM THE HUB. A NEW LINE WAS PLACED, THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7591936 ↗MalfunctionJun 11, 2018Crack
IT WAS REPORTED THAT THE FEMORAL LINE CATHETER OF THE SINGLE LUMEN PRESSURE MONITORING SET WAS FOUND TO BE CRACKED DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7588491 ↗
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- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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