Groshong Midline Catheter 7715435Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741075230), received between Apr 11, 2016 and Mar 12, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHILE POSITIONING THE DEVICE, PRIOR TO USE ON THE PATIENT, A CATHETER RUPTURE WAS NOTED AT 2 CM NEAR THE INSERTION POINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9823732 ↗
• MalfunctionSep 22, 2017Product Quality Problem

  IT WAS REPORTED BY MS&S THAT NURSE CALLED AND STATED SHE WAS IN THE MIDDLE OF A PROCEDURE PLACING A GROSHONG MIDLINE. WHEN SHE OPENED THE KIT, THE KIT WITHIN THE KIT THAT CONTAINS THE CATHETER ITSELF LOOKED AS IF IT HAD BEEN OPENED AND TAPED CLOSED. SHE OPENED ANOTHER PACKAGE TO SEE IF IT WAS A FLUKE AND IT WAS THE SAME IN THE SECOND KIT AS WELL.

  Patient problems: No Information

  MAUDE report 6886469 ↗
• MalfunctionMay 4, 2016Detachment Of Device Component

  (B)(4) IT WAS REPORTED THAT A PATIENT WITH LUNG CANCER AND A TRACHEOSTOMY TUBE WAS BEING MECHANICALLY VENTILATED AND WAS HOSPITALIZED FOR ACUTE RESPIRATORY FAILURE. A GROSHONG MIDLINE CATHETER WAS PLACED VIA THE BASILIC VEIN OF RIGHT ARM WITH ULTRASOUND ON (B)(6) 2016. THE CATHETER WAS PLACED FOR BLOOD SAMPLING AND INTRAVENOUS THERAPY INFUSIONS. THE CATHETER WAS REPORTEDLY PLACED WITHOUT DIFFICULTY OR COMPLICATIONS WITH 1.5 CM OF THE CATHETER LEFT OUTSIDE THE BODY. THE DEVICE WAS STABILIZED WITH A TRANSPARENT DRESSING FILM INSTEAD OF A STATLOCK. IT WAS STATED THAT THE DEVICE WAS TREATED AND CONTROLLED IN ACCORDANCE TO HOSPITAL PROCEDURE. ON (B)(6), AT 4 AM, THE PATIENT WAS HIGHLY AGITATED AND WAS TAKEN OFF THE TRACHEOSTOMY TUBE AND THE MIDLINE CATHETER. THE NURSE FOUND THAT AT THE INSERTION SITE ON THE PATIENT'S SKIN THAT THE GRAY AND PURPLE DEVICE, WITH THE LUER-LOCK, HAD REPORTEDLY BEEN DETACHED FROM THE BLUE CONE OF THE CATHETER. IT WAS SAID THAT THE BLUE CONE HAD BEEN TORN FROM THE GRAY PORTION, LEAVING ONLY THE CONNECTOR BLUNT ATTACHING THE TWO PIECES TOGETHER. THE CATHETER WAS REMOVED TO AVOID MIGRATION IN THE VENOUS CIRCULATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5632236 ↗
• InjuryApr 11, 2016Detachment Of Device Component; Migration or Expulsion of Device

  A NURSE REPORTED THAT THEY FOUND A CATHETER DETACHMENT AND MIGRATION OF A PORTION OF THE CATHETER. THE MIGRATED PORTION WAS FOUND IN THE RIGHT ATRIUM AND WAS REMOVED AT ANOTHER HOSPITAL. THE PATIENT IS REPORTEDLY IN GOOD CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5567242 ↗