CAREFLOW(TM) 1 LUMEN 4FR X 200MM 681649Recalls & reported problems
Argon Critical Care Systems Singapore Pte. Ltd. · Kits Contents : Catheter 4FR OD 1.45mmx200mm; J guidewire OD 0.64mmx450mm, Steel Needle Introducer 17G OD 1.4mmx70mm, Dilator 5FR OD 1.7mm ID 0.66mm · 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 00886333616497), received between Oct 20, 2022 and Oct 20, 2022 — classified as 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pneumothorax1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A STUDY ALLEGES THAT ON POSTOPERATIVE DAY 4, PATIENT COMPLAINED OF CHEST PAIN AND DYSPNEA AFTER PLACEMENT OF A CENTRAL VENOUS CATHETER. CHEST X-RAY SHOWED BILATERAL PNEUMOTHORAX. PNEUMOTHORAX TREATED WITH BILATERAL THORACOTOMY TUBES (20FR) FOR 4 DAYS.
Patient problems: Pneumothorax
MAUDE report 15638444 ↗
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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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