JelcoRecalls & reported problems across all models
Icu Medical, Inc. · 101 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,299
- Deaths reported
- 0
- Injuries reported
- 109
- Recalls
- 0
We found 101 models of Jelco by Icu Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,299 adverse event reports in the FDA's MAUDE database, received between Feb 29, 2016 and Sep 30, 2026 — classified as 109 injuries, 1,190 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (320 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Jelco problems
Device problems
- Fluid/Blood Leak320
- Break145
- Dull, Blunt106
- Detachment of Device or Device Component89
- Difficult to Advance63
- Protective Measures Problem54
- Product Quality Problem53
- Leak/Splash52
Patient problems
- No Clinical Signs, Symptoms or Conditions738
- No Consequences Or Impact To Patient182
- No Known Impact Or Consequence To Patient105
- Pain64
- Insufficient Information55
- Foreign Body In Patient49
- Needle Stick/Puncture43
- Device Embedded In Tissue or Plaque22
Jelco models
101 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Jelco 3260Catheter,intravascular,therapeutic,short-term less than 30 days93 reports
- Jelco 402510Needle, hypodermic, single lumen91 reports
- Jelco 3266Catheter,intravascular,therapeutic,short-term less than 30 days85 reports
- Jelco 3066Catheter,intravascular,therapeutic,short-term less than 30 days80 reports
- Jelco 3060Catheter,intravascular,therapeutic,short-term less than 30 days68 reports
- Jelco 3267Catheter,intravascular,therapeutic,short-term less than 30 days58 reports
- Jelco 3263Catheter,intravascular,therapeutic,short-term less than 30 days53 reports
- Jelco 96000Tubes, vials, systems, serum separators, blood collection50 reports
- Jelco 3067Catheter,intravascular,therapeutic,short-term less than 30 days45 reports
- Jelco 4292Needle, hypodermic, single lumen44 reports
- Jelco 4291Needle, hypodermic, single lumen43 reports
- Jelco 3080Catheter,intravascular,therapeutic,short-term less than 30 days38 reports
- Jelco 3063Catheter,intravascular,therapeutic,short-term less than 30 days37 reports
- Jelco 96004Tubes, vials, systems, serum separators, blood collection33 reports
- Jelco 3073Catheter,intravascular,therapeutic,short-term less than 30 days33 reports
- Jelco 306501Catheter,intravascular,therapeutic,short-term less than 30 days23 reports
- Jelco 982312DNeedle, hypodermic, single lumen20 reports
- Jelco 4290Needle, hypodermic, single lumen19 reports
- Jelco 3055Catheter,intravascular,therapeutic,short-term less than 30 days18 reports
- Jelco 328000Catheter,intravascular,therapeutic,short-term less than 30 days17 reports
- Jelco 305706Catheter,intravascular,therapeutic,short-term less than 30 days16 reports
- Jelco 4288Needle, hypodermic, single lumen16 reports
- Jelco 305006Catheter,intravascular,therapeutic,short-term less than 30 days15 reports
- Jelco 402558Needle, hypodermic, single lumen13 reports
- Jelco 335603Catheter,intravascular,therapeutic,short-term less than 30 days13 reports
- Jelco 3265Catheter,intravascular,therapeutic,short-term less than 30 days12 reports
- Jelco EL31915Needle, hypodermic, single lumen11 reports
- Jelco 4234Needle, hypodermic, single lumen11 reports
- Jelco 326800Catheter,intravascular,therapeutic,short-term less than 30 days10 reports
- Jelco 4140Tubes, vials, systems, serum separators, blood collection9 reports
- Jelco 3083Catheter,intravascular,therapeutic,short-term less than 30 days9 reports
- Jelco 4293Needle, hypodermic, single lumen9 reports
- Jelco 338300Catheter,intravascular,therapeutic,short-term less than 30 days8 reports
- Jelco 432215Needle, hypodermic, single lumen7 reports
- Jelco 328700Catheter,intravascular,therapeutic,short-term less than 30 days7 reports
- Jelco 328600Catheter,intravascular,therapeutic,short-term less than 30 days7 reports
- Jelco 4236Needle, hypodermic, single lumen7 reports
- Jelco 982312Needle, hypodermic, single lumen7 reports
- Jelco 4429-1SYRINGE, ANTISTICK6 reports
- Jelco 305306Catheter,intravascular,therapeutic,short-term less than 30 days6 reports
- Jelco 3085Catheter,intravascular,therapeutic,short-term less than 30 days6 reports
- Jelco 308700Catheter,intravascular,therapeutic,short-term less than 30 days6 reports
- Jelco 328500Catheter,intravascular,therapeutic,short-term less than 30 days6 reports
- Jelco 328300Catheter,intravascular,therapeutic,short-term less than 30 days6 reports
- Jelco 405311Catheter,intravascular,therapeutic,short-term less than 30 days6 reports
- Jelco 4277Needle, hypodermic, single lumen6 reports
- Jelco SB5021Needle, hypodermic, single lumen6 reports
- Jelco 402310Needle, hypodermic, single lumen5 reports
- Jelco 308600Catheter,intravascular,therapeutic,short-term less than 30 days5 reports
- Jelco 405011Catheter,intravascular,therapeutic,short-term less than 30 days5 reports
- Jelco EL1915Needle, hypodermic, single lumen5 reports
- Jelco 402515Needle, hypodermic, single lumen4 reports
- Jelco 982106Needle, hypodermic, single lumen4 reports
- Jelco 96000STubes, vials, systems, serum separators, blood collection4 reports
- Jelco 982112DNeedle, hypodermic, single lumen4 reports
- Jelco 972312Needle, hypodermic, single lumen3 reports
- Jelco 972112Needle, hypodermic, single lumen3 reports
- Jelco 96005Tubes, vials, systems, serum separators, blood collection3 reports
- Jelco 402115Needle, hypodermic, single lumen3 reports
- Jelco 3056Catheter,intravascular,therapeutic,short-term less than 30 days3 reports
- Jelco 4285Needle, hypodermic, single lumen3 reports
- Jelco 982306Needle, hypodermic, single lumen3 reports
- Jelco 4427-TBSYRINGE, ANTISTICK2 reports
- Jelco 4430-3SYRINGE, ANTISTICK2 reports
- Jelco 401815Needle, hypodermic, single lumen2 reports
- Jelco 4141Tubes, vials, systems, serum separators, blood collection2 reports
- Jelco 306201Catheter,intravascular,therapeutic,short-term less than 30 days2 reports
- Jelco 335703Catheter,intravascular,therapeutic,short-term less than 30 days2 reports
- Jelco 326500Catheter,intravascular,therapeutic,short-term less than 30 days2 reports
- Jelco 326700Catheter,intravascular,therapeutic,short-term less than 30 days2 reports
- Jelco 326600Catheter,intravascular,therapeutic,short-term less than 30 days2 reports
- Jelco 405511Catheter,intravascular,therapeutic,short-term less than 30 days2 reports
- Jelco 4286Needle, hypodermic, single lumen2 reports
- Jelco 4237Needle, hypodermic, single lumen2 reports
- Jelco 4275Needle, hypodermic, single lumen2 reports
- Jelco 982512DNeedle, hypodermic, single lumen2 reports
- Jelco 4319Syringe, piston1 report
- Jelco 972306Needle, hypodermic, single lumen1 report
- Jelco 972512Needle, hypodermic, single lumen1 report
- Jelco 4428-5SYRINGE, ANTISTICK1 report
- Jelco 432310SYRINGE, ANTISTICK1 report
- Jelco 401810Needle, hypodermic, single lumen1 report
- Jelco 402705Needle, hypodermic, single lumen1 report
- Jelco 432015Needle, hypodermic, single lumen1 report
- Jelco 4142Tubes, vials, systems, serum separators, blood collection1 report
- Jelco 4139Needle, hypodermic, single lumen1 report
- Jelco 3048Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- Jelco 3070Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- Jelco 335503Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- Jelco 335903Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- Jelco 326200Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- Jelco 326000Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- Jelco 328200Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- Jelco 405611Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- Jelco 441811Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- Jelco 446611Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- Jelco 505311Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- Jelco 982312D-2Tubes, vials, systems, serum separators, blood collection1 report
- Jelco 4281Needle, hypodermic, single lumen1 report
- Jelco 982112Needle, hypodermic, single lumen1 report
Recent Jelco adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953910 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953337 ↗MalfunctionSep 28, 2026Backflow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924675 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902444 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that catheter advancement was more resistant than expected during insertion. In addition, blood was observed pooling at the end of the blue hub or fully bleeding from the hub, indicating that the blood control valve did not function as intended. There was patient involvement and no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883393 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
It was reported that during insertion of the Jelco ViaValve Safety IV Catheter, blood was observed oozing from the needle guard upon placement of the peripheral intravenous (PIV) catheter. There was patient involvement with no harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873277 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
It was reported that the product seems to be leaked. Paramedic had the device on top of a blood culture bottle, and there was a leak he looked down and found blood all over his shoe. When the rubber separated from the needle, blood flows freely. This occurred when moved from one blood culture bottle to the next. There was a patient involvement and there were no additional adverse consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855595 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
It was reported that the product seems to be leaked. Paramedic had the device on top of a blood culture bottle, and there was a leak he looked down and found blood all over his shoe. When the rubber separated from the needle, blood flows freely. This occurred when moved from one blood culture bottle to the next. There was a patient involvement and there were no additional adverse consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855377 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
It was reported that the product seems to be leaked. Paramedic had the device on top of a blood culture bottle, and there was a leak he looked down and found blood all over his shoe. When the rubber separated from the needle, blood flows freely. This occurred when moved from one blood culture bottle to the next. There was a patient involvement and there were no additional adverse consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855173 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845441 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
It was stated in the report that the nurse noticed that the extension tube was leaking blood during blood collection. There was patient involvement but no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819326 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
It was stated in the report that the nurse noticed the plunger was leaking blood during blood collection. There was patient involvement but no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819093 ↗MalfunctionSep 17, 2026Fluid/Blood Leak
It was stated in the report that the extension tube was leaking blood. There was patient involvement and no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802256 ↗MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741099 ↗MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741098 ↗
Other Icu Medical, Inc. products
- CADD123 models · 53,012 reports · 21 recalls
- Medfusion16 models · 13,114 reports · 5 recalls
- Bivona469 models · 2,811 reports · 29 recalls
- Level 152 models · 3,733 reports · 1 recall
- Portex409 models · 3,479 reports · 5 recalls
- Cleo6 models · 2,782 reports
- Pneupac23 models · 1,972 reports
- Medex98 models · 774 reports · 23 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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