Jelco 335603Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10351688071446), received between Jul 18, 2018 and Feb 18, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K012128); they may or may not involve this specific model.

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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHILE THE SMITHS MEDICAL CATHETER WAS INTO PATIENT'S VEIN, THE USER COULD NOT EASILY REMOVE THE MANDREL FROM THE CATHETER WHICH LED TO PAIN AND WOUND FOR PATIENT. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11341524 ↗
• MalfunctionFeb 18, 2021Difficult to Remove; Difficult to Remove

  WHILE CATHETER WAS INTO PATIENT'S VEIN, THE USER COULD NOT EASILY REMOVE THE MANDREL FROM THE CATHETER WHICH LED TO PAIN AND WOUND FOR PATIENT. ISSUE OCCURRED *FREQUENTLY DURING THE LAST FEW MONTHS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11341521 ↗
• MalfunctionFeb 18, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHILE THE SMITHS MEDICAL CATHETER WAS INTO PATIENT'S VEIN, THE USER COULD NOT EASILY REMOVE THE MANDREL FROM THE CATHETER WHICH LED TO PAIN AND WOUND FOR PATIENT. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11341518 ↗
• MalfunctionJul 18, 2018Difficult or Delayed Separation; Difficult or Delayed Separation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO® ACUVANCE® SAFETY I.V. CATHETER WAS NOT SEPARATING EASILY AT THE HUB UPON THREADING THE PLASTIC CATHETER INTO THE PATIENT'S VEIN. REPORTED USE OF EXTRA FORCE WAS NEEDED TO SEPARATE WITH A CONCERN OF THIS POSSIBLY COLLAPSING THE VEIN FROM THE PRESSURE. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7699958 ↗
• MalfunctionJul 18, 2018Difficult or Delayed Separation; Difficult or Delayed Separation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO® ACUVANCE® SAFETY I.V. CATHETER WAS NOT SEPARATING EASILY AT THE HUB UPON THREADING THE PLASTIC CATHETER INTO THE PATIENT'S VEIN. REPORTED USE OF EXTRA FORCE WAS NEEDED TO SEPARATE WITH A CONCERN OF THIS POSSIBLY COLLAPSING THE VEIN FROM THE PRESSURE. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7699930 ↗
• MalfunctionJul 18, 2018Difficult or Delayed Separation; Difficult or Delayed Separation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO® ACUVANCE® SAFETY I.V. CATHETER WAS NOT SEPARATING EASILY AT THE HUB UPON THREADING THE PLASTIC CATHETER INTO THE PATIENT'S VEIN. REPORTED USE OF EXTRA FORCE WAS NEEDED TO SEPARATE WITH A CONCERN OF THIS POSSIBLY COLLAPSING THE VEIN FROM THE PRESSURE. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7699892 ↗
• MalfunctionJul 18, 2018Difficult or Delayed Separation; Difficult or Delayed Separation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO® ACUVANCE® SAFETY I.V. CATHETER WAS NOT SEPARATING EASILY AT THE HUB UPON THREADING THE PLASTIC CATHETER INTO THE PATIENT'S VEIN. REPORTED USE OF EXTRA FORCE WAS NEEDED TO SEPARATE WITH A CONCERN OF THIS POSSIBLY COLLAPSING THE VEIN FROM THE PRESSURE. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7699867 ↗
• MalfunctionJul 18, 2018Difficult or Delayed Separation; Difficult or Delayed Separation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO® ACUVANCE® SAFETY I.V. CATHETER WAS NOT SEPARATING EASILY AT THE HUB UPON THREADING THE PLASTIC CATHETER INTO THE PATIENT'S VEIN. REPORTED USE OF EXTRA FORCE WAS NEEDED TO SEPARATE WITH A CONCERN OF THIS POSSIBLY COLLAPSING THE VEIN FROM THE PRESSURE. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7699824 ↗
• MalfunctionJul 18, 2018Difficult or Delayed Separation; Difficult or Delayed Separation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO® ACUVANCE® SAFETY I.V. CATHETER WAS NOT SEPARATING EASILY AT THE HUB UPON THREADING THE PLASTIC CATHETER INTO THE PATIENT'S VEIN. REPORTED USE OF EXTRA FORCE WAS NEEDED TO SEPARATE WITH A CONCERN OF THIS POSSIBLY COLLAPSING THE VEIN FROM THE PRESSURE. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7699761 ↗
• MalfunctionJul 18, 2018Difficult or Delayed Separation; Difficult or Delayed Separation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO® ACUVANCE® SAFETY I.V. CATHETER WAS NOT SEPARATING EASILY AT THE HUB UPON THREADING THE PLASTIC CATHETER INTO THE PATIENT'S VEIN. REPORTED USE OF EXTRA FORCE WAS NEEDED TO SEPARATE WITH A CONCERN OF THIS POSSIBLY COLLAPSING THE VEIN FROM THE PRESSURE. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7699665 ↗
• MalfunctionJul 18, 2018Difficult or Delayed Separation; Difficult or Delayed Separation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO® ACUVANCE® SAFETY I.V. CATHETER WAS NOT SEPARATING EASILY AT THE HUB UPON THREADING THE PLASTIC CATHETER INTO THE PATIENT'S VEIN. REPORTED USE OF EXTRA FORCE WAS NEEDED TO SEPARATE WITH A CONCERN OF THIS POSSIBLY COLLAPSING THE VEIN FROM THE PRESSURE. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7699596 ↗
• MalfunctionJul 18, 2018Difficult or Delayed Separation; Difficult or Delayed Separation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO® ACUVANCE® SAFETY I.V. CATHETER WAS NOT SEPARATING EASILY AT THE HUB UPON THREADING THE PLASTIC CATHETER INTO THE PATIENT'S VEIN. REPORTED USE OF EXTRA FORCE WAS NEEDED TO SEPARATE WITH A CONCERN OF THIS POSSIBLY COLLAPSING THE VEIN FROM THE PRESSURE. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7699561 ↗
• MalfunctionJul 18, 2018Difficult or Delayed Separation; Difficult or Delayed Separation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO® ACUVANCE® SAFETY I.V. CATHETER WAS NOT SEPARATING EASILY AT THE HUB UPON THREADING THE PLASTIC CATHETER INTO THE PATIENT'S VEIN. REPORTED USE OF EXTRA FORCE WAS NEEDED TO SEPARATE WITH A CONCERN OF THIS POSSIBLY COLLAPSING THE VEIN FROM THE PRESSURE. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7699450 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012128. One submission often covers many models, so check the product and lot details in each record.

• Z-0789-2017 · Nov 21, 2016 · Terminated
  Acuvance2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipun