Argyle 8888560805Recalls & reported problems
Cardinal Health, Inc. · Trocar Catheter,Sharp Tip · Class 2
Data updated Oct 13, 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 10884521050310), received between Nov 15, 2021 and Apr 4, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Difficult to Advance1
- Difficult to Remove1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance
CUSTOMER REPORTS: AN 8FR CHEST TUBE NEEDLE STUCK INTO THE CHEST TUBE. WE WERE UNABLE TO REMOVE OR USE IT TO INSERT THE TUBE. THE CHEST TUBE WAS BEING PLACED IN AN EMERGENCY AND AS SUCH INSERTION WAS DELAYED AS ANOTHER TUBE HAD TO BE FOUND AND INSERTED. THE IMPACT TO THE PATIENT WAS PROLONGED CARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13997699 ↗MalfunctionNov 15, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
THE CUSTOMER REPORTED THAT THEY WERE ABOUT TO USE A CATHETER ON A BABY THAT WAS CODING IN THE NICU AND THEY WEREN¿T ABLE TO GET THE CATHETER TO DEPLOY FROM THE TIP AND IT SEEMS LIKE THEY ARE ADHERED TOGETHER. THE PHYSICIAN DISCOVERED THE ISSUE BEFORE USING IT ON THE BABY, SO THERE WAS NO HARM TO THE PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12814082 ↗
Other Trocar devices
- BRK™ G407208St. Jude Medical Cardiovascular Division · Trocar3 deaths75 reports
- BRK™ 407200St. Jude Medical Cardiovascular Division · Trocar4 deaths71 reports
- NA EP003994SMedtronic, Inc. · Trocar60 reports
- Cook G02364Cook Incorporated · Trocar1 recall5 reports
- HeartSpan® 00884450489345Merit Medical Systems, Inc. · Trocar1 recall1 death2 reports
- Cook G01377Cook Incorporated · Trocar1 recall2 reports
- HeartSpan® 00884450489369Merit Medical Systems, Inc. · Trocar1 recall0 reports
- Endrys G19261Cook Incorporated · Trocar1 recall0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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