Cook G03282Recalls & reported problems
Cook Incorporated · Pericardiocentesis Set · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002032828), received between Jul 26, 2016 and Mar 24, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Aspiration Issue” (1 report).
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
- Aspiration Issue1
- Difficult to Remove1
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2020Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 9873689 ↗MalfunctionApr 3, 2019Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE WIRE GUIDE OF A COOK PERICARDIOCENTESIS CATHETER SET WAS UNABLE TO BE WITHDRAWN FROM THE CATHETER DURING AN UNKNOWN PROCEDURE. THE PHYSICIAN HAD TO REMOVE BOTH THE CATHETER AND THE WIRE GUIDE AT THE SAME TIME. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAVE BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8479832 ↗MalfunctionJul 26, 2016Aspiration Issue; Aspiration Issue
IT WAS REPORTED DURING A PERICARDIAL DRAINAGE FLUID PROCEDURE THAT AIR WAS ASPIRATED INSTEAD OF FLUID IN THE PERICARDIUM. A SYRINGE WAS ATTACHED TO ANOTHER PORT OF THE SAME THREE-WAY STOPCOCK TO RE-TRY THE ASPIRATION OF FLUID FROM THE PERICARDIUM. THUS, RESULTING IN SUCCESSFUL ASPIRATION. THE PROCEDURE WAS FINISHED WITH THE DEVICE. THERE WERE NOT ANY REPORTED ADVERSE EVENTS TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5821906 ↗
Other CATHETER, IRRIGATION devices
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- Navarre NNU8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION736 reports
- BLAKE 2227Ethicon Inc. · CATHETER, IRRIGATION331 reports
- Navarre NNU6LPTBard Access Systems, Inc. · CATHETER, IRRIGATION211 reports
- Navarre Opti-Drain NOD10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION178 reports
- Navarre NNU10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION127 reports
- BLAKE 2233Ethicon Inc. · CATHETER, IRRIGATION114 reports
- Vasoshield VH-5001Maquet Cardiovascular LLC · Catheter, Irrigation1 recall27 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
- 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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