EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Stylet 5903190Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741013690), received between Sep 4, 2018 and Oct 20, 2023 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Defective Component” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2023Suction Problem; Migration; Suction Problem; Migration

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT IN THE RIGHT INTERNAL JUGULAR, THE CATHETER ALLEGEDLY HAD HARD TO GET THE BLOOD DRAW BACK. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY MIGRATED FROM THE RIGHT ATRIUM TO THE LEFT ATRIUM. REPORTEDLY, SURGERY WAS DONE TO PLACE BACK THE DEVICE IN THE CORRECT ATRIUM. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17981539 ↗
• MalfunctionMar 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY EIGHT MONTHS POST DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DIALYSIS CATHETER ALLEGEDLY HAD CRACK ON THE Y SECTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16563424 ↗
• MalfunctionDec 23, 2021Fracture; Fracture

  IT WAS REPORTED THAT ONE YEAR AND THREE MONTHS POST DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD A BREAK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13073825 ↗
• MalfunctionMay 6, 2020Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER PREPARATION, THE TIP ON Y CONNECTOR ALLEGEDLY BROKE OFF PRIOR TO USE ON PATIENT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10030424 ↗
• MalfunctionJul 18, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT THE DIALYSIS KIT ALLEGEDLY CONTAINED THE INCORRECT DILATOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8803037 ↗
• MalfunctionJul 2, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION FOR A DIALYSIS CATHETER PLACEMENT PROCEDURE IN THE INTERNAL JUGULAR, THE TIP OF THE TUNNELER ALLEGEDLY BROKE OFF AS THE CATHETER WAS ATTEMPTED TO ATTACH TO THE TUNNELER. ANOTHER CATHETER AND TUNNELER WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8754026 ↗
• MalfunctionJun 6, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PROCEDURE THE TUNNELER TIP ALLEGEDLY BROKE OFF IN TWO PLACES AS IT WAS BEING INSERTED INTO THE PEEL-A-WAY SHEATH. IT WAS ALSO REPORTED THAT ALLEGEDLY ONE OF THE PIECES WAS STILL INSIDE THE TIP OF THE CATHETER, THEREFORE THE CATHETER WAS REMOVED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675547 ↗
• MalfunctionMay 17, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING USE OF A EQUISTREAM CATHETER, THE TIP ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 8621665 ↗
• MalfunctionMay 13, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION A PIECE OF THE CATHETER ALLEGEDLY DETACHED. REPORTEDLY, A NEW KIT WAS OPENED TO COMPLETED THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8604354 ↗
• MalfunctionApr 29, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE TIP OF THE TUNNELER ALLEGEDLY BROKE, AND THE TIP LODGED INSIDE THE CATHETER. REPORTEDLY, THE TIP WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8562883 ↗
• MalfunctionApr 17, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE TUNNELER TIP ALLEGEDLY BROKE WITHIN THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524117 ↗
• MalfunctionApr 17, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE TUNNELER TIP ALLEGEDLY BROKE WITHIN THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524001 ↗
• MalfunctionApr 8, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLASTIC TIP OF THE TUNNELER ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8494045 ↗
• MalfunctionApr 2, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE TIP OF THE TUNNELER COMPONENT BROKE IN THE CATHETER DURING THE INSERTION PROCESS. IT WAS FURTHER REPORTED THAT A NEW KIT WAS USED WHERE THE TUNNELER COMPONENT BROKE A SECOND TIME DURING THE SAME PROCESS. REPORTEDLY, A THIRD KIT WAS OPENED AND CATHETER WAS PLACED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8475035 ↗
• MalfunctionApr 2, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE TIP OF THE TUNNELER COMPONENT BROKE IN THE CATHETER DURING THE INSERTION PROCESS. IT WAS FURTHER REPORTED THAT A NEW KIT WAS USED WHERE THE TUNNELER COMPONENT BROKE A SECOND TIME DURING THE SAME PROCESS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8474885 ↗
• MalfunctionSep 4, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A DIALYSIS CATHETER WAS IDENTIFIED AS ALLEGEDLY WIDENED AND FLATTENED NEAR THE HUB WITH DISCOLORATION. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT FUNCTIONING AND WAS REMOVED AND A NEW CATHETER WAS INSERTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7842343 ↗