CAREFLOW(TM) 2 LUMEN 4FR X 100MM 681627Recalls & reported problems
Argon Critical Care Systems Singapore Pte. Ltd. · Kits Contents : Catheter 4FR OD 1.45mmx100mm; J guidewire OD 0.46mmx350mm, Steel Needle Introducer 22G OD 0.75mmx40mm; Floswitch(TM) Overneedle Introducer 20G OD1.0mmx45mm, Dilator 5FR OD 1.7mm ID 0.66mm &Floswitch(TM) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886333616275), received between Aug 25, 2015 and Aug 25, 2015 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Use of Device Problem1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2015Use of Device Problem; Improper or Incorrect Procedure or Method
HOLE AT THE END OF PROXIMAL LUMEN OF CV CATHETER. ONE X USED CATHETER RETURNED TO ARGON OFFICE IN (B)(4) FOR FURTHER EXAMINATION.
Patient problems: No Information
MAUDE report 5048866 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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