Midline Catheter ML4S20Recalls & reported problems
Medical Components, Inc. · 4F X 20CM SINGLE LUMEN MIDLINE BASIC NURSING SET · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884908030662), received between Jun 21, 2017 and Oct 18, 2017 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Knotted” (3 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
- Knotted3
- Difficult to Remove1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2017Knotted; Knotted
GUIDEWIRE TIP KNOTTED IN VEIN DURING INSERTION PROCEDURE-UNABLE TO REMOVE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6958290 ↗InjurySep 13, 2017Knotted; Knotted
DURING MIDLINE INSERTION NEEDLE WAS INSERTED WITH GOOD VENOUS REFLUX. WHEN THE WIRE WAS INTRODUCED IT WAS POSSIBLE TO ADVANCE ONLY A FEW CENTIMETERS UNTIL IT STOPPED. DURING WITHDRAWAL OF THE GUIDEWIRE RESISTANCE WAS NOTED. A KNOT WAS NOTED WITH ULTRASOUND. SURGERY WAS REQUIRED TO REMOVE THE WIRE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6861483 ↗InjuryJun 21, 2017Knotted; Difficult to Remove
DURING CATHETER PLACEMENT, METAL GUIDEWIRE KNOTTED MAKING REMOVAL DIFFICULT.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 6657234 ↗
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
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- Groshong NXT ClearVue Catheter 7655405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,536 reports
- PowerPICC Catheter 3174118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall402 reports
- L-Cath™ S/L PICC S/L 26GA (1.9F) x 30cmArgon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days2 recalls245 reports
- PowerPICC SOLO2 Catheter 1194108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls216 reports
- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
- PowerPICC® Catheters 1174108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall222 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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