EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Stylet 5903230Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00801741013706), received between Feb 16, 2016 and Dec 29, 2025 — classified as 4 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Defective Component” (18 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2025Nonstandard Device; Air/Gas in Device; Nonstandard Device; Air/Gas in Device

  ON (B)(6) 2025, A PATIENT UNDERWENT TUNNELED HEMODIALYSIS HD CATHETER PLACEMENT. DURING THE PLACEMENT OF A TUNNELED HEMODIALYSIS HD LINE, IT WAS REPORTED THAT THE VALVE OF THE PEEL-AWAY SHEATH MALFUNCTIONED AND DID NOT PREVENT AIR FROM ENTERING THE PATIENT'S VENOUS SYSTEM. IMMEDIATE CORRECTIVE ACTIONS INCLUDED PLACING THE PATIENT ON A HIGHER OXYGEN LEVEL AND POSITIONING THEM ON THEIR LEFT SIDE. THE PATIENT WAS STABILIZED, AND THE PHYSICIAN DEEMED IT SAFE TO CONTINUE AND COMPLETE THE PROCEDURE. HOWEVER, UPON RETURNING TO THE WARD, THE PATIENT BEGAN TO DECOMPENSATE, REQUIRING INTUBATION AND TRANSFER TO THE ICU FOR FURTHER MANAGEMENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 23904087 ↗
• InjuryJul 25, 2025Air/Gas in Device; Air/Gas in Device

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE EQUISTREAM SPLIT TIP. DURING THE PROCEDURE THE VALVE WAS ALLEGEDLY FOUND NOT PREVENTING AIR FORM ENTERING THE VEIN. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED AIR ENTERED THE PATIENTS VEIN VIA THE SHEATH. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 22612744 ↗
• InjuryJul 15, 2025Fracture; Material Separation; Air/Gas in Device; Fracture; Material Separation; Air/Gas in Device

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A DIALYSIS CATHETER IMPLANT USING EQUISTREAM SPLIT TIP VIA JUGULAR TO RIGHT ATRIUM, THE VALVE WAS BROKEN ON AIR GUARD DEVICES. FURTHER, AIR EMBOLISM WAS FOUND VIA PEEL AWAY SHEATH AND PATIENT CURRENTLY IN ICU FOR POST OBSERVATION. PROCEDURE WAS COMPLETED NORMALLY. CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 22504539 ↗
• InjuryJul 15, 2025Fracture; Material Separation; Air/Gas in Device; Fracture; Material Separation; Air/Gas in Device

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A DIALYSIS CATHETER IMPLANT USING EQUISTREAM SPLIT TIP VIA JUGULAR TO RIGHT ATRIUM, THE VALVE WAS BROKEN ON AIR GUARD DEVICES. FURTHER, AIR EMBOLISM WAS FOUND VIA PEEL AWAY SHEATH. PATIENT WENT HOME POST OBSERVATION. PROCEDURE WAS COMPLETED NORMALLY. CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 22504535 ↗
• MalfunctionMay 27, 2025Material Discolored; Material Opacification; Stretched; Material Protrusion/Extrusion; Material Discolored; Material Opacification; Stretched; Material Protrusion/Extrusion

  A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING EQUISTREAM. ON (B)(6) 2025, POST PROCEDURE IT WAS FOUND THAT THE CATHETER ALLEGEDLY HAD OPACITY OR WHITE DISCOLORATION AFTER THE CVC HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089345 ↗
• MalfunctionJul 27, 2022Fracture; Difficult to Remove; Material Separation; Stretched; Failure to Advance; Fracture; Difficult to Remove; Material Separation; Stretched; Failure to Advance

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, DEVICE ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15110957 ↗
• MalfunctionMay 23, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION, THE TUNNELER PLASTIC TIP WAS ALLEGEDLY IDENTIFIED AS BROKEN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8636424 ↗
• MalfunctionMay 23, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION, THE TUNNELER PLASTIC TIP WAS ALLEGEDLY IDENTIFIED AS BROKEN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8636082 ↗
• MalfunctionMay 23, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION, THE TUNNELER PLASTIC TIP WAS ALLEGEDLY IDENTIFIED AS BROKEN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8636016 ↗
• MalfunctionApr 29, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE TIP OF THE TUNNELER ALLEGEDLY BROKE AFTER THE CATHETER HAD BEEN SUCCESSFULLY PLACED, AND THE TUNNELER HAD BEEN REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8562885 ↗
• MalfunctionApr 26, 2019Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT THE TIP OF A DIALYSIS CATHETER ALLEGEDLY BROKE OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8556106 ↗
• 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 8491878 ↗
• MalfunctionMar 14, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER INSERTION, THE TUNNELER COMPONENT ALLEGEDLY BROKE OFF IN THE CATHETER. IT WAS FURTHER REPORTED THAT ANOTHER KIT WAS USED AND THE SAME OCCURRED; HOWEVER, THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8422814 ↗
• MalfunctionMar 13, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT WHEN TUNNELING THE CATHETER, THE WHITE TIP OF THE TUNNELER ALLEGEDLY BROKE. REPORTEDLY, A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417353 ↗
• MalfunctionMar 8, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT PRIOR TO HEMODIALYSIS CATHETER PLACEMENT, THE TUNNELER TIP BROKE OFF AND WAS RENDERED UNUSABLE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8406192 ↗
• MalfunctionMar 7, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT PRIOR TO HEMODIALYSIS CATHETER PLACEMENT, THE TUNNELER TIP BROKE OFF AND WAS RENDERED UNUSABLE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8401480 ↗
• MalfunctionMar 7, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT PRIOR TO HEMODIALYSIS CATHETER PLACEMENT, THE TUNNELER TIP BROKE OFF AND WAS RENDERED UNUSABLE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8401477 ↗
• MalfunctionJan 3, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT WHEN TUNNELING THE CATHETER, THE WHITE TIP OF THE TUNNELER ALLEGEDLY BROKE. REPORTEDLY, A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8214673 ↗
• MalfunctionJan 3, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT WHEN TUNNELING THE CATHETER, THE WHITE TIP OF THE TUNNELER ALLEGEDLY BROKE. REPORTEDLY, A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8214652 ↗
• MalfunctionJan 3, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT WHEN TUNNELING THE CATHETER, THE WHITE TIP OF THE TUNNELER ALLEGEDLY BROKE. REPORTEDLY, A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8214531 ↗
• MalfunctionJan 3, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT WHEN TUNNELING THE CATHETER, THE WHITE TIP OF THE TUNNELER ALLEGEDLY BROKE. REPORTEDLY, A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8213987 ↗
• MalfunctionJan 3, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT WHEN TUNNELING THE CATHETER, THE WHITE TIP OF THE TUNNELER ALLEGEDLY BROKE. REPORTEDLY, A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8213946 ↗
• MalfunctionDec 4, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT DURING INSERTION, THE WHITE STEM ON THE TUNNELER ALLEGEDLY BROKE AND WAS UNABLE TO BE RETRIEVED WITHIN THE DIALYSIS CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8131379 ↗
• MalfunctionDec 4, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT DURING INSERTION, THE WHITE STEM ON THE TUNNELER ALLEGEDLY BROKE AND WAS UNABLE TO BE RETRIEVED WITHIN THE DIALYSIS CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8131260 ↗
• MalfunctionJul 7, 2017Break

  IT WAS REPORTED THAT EQUISTREAM WAS INSERTED (B)(6) 2016. IT WAS STATED THAT THE VENOUS CLAMP ON THE CATHETER BROKE. IT WAS REPORTED THAT THE CLAMP HAD BEEN IN PLACE FOR 9 MONTHS AND BROKE AT THE BASE, NO PROBLEMS WERE NOTICED WITH ENGAGING THE CLAMP PRIOR TO THE BREAK. THE CATHETER WAS ACCESSED FOR INFUSION AND ASPIRATION 3 TIMES A WEEK. THE CATHETER AND DRESSING WERE CLEANED EVERY WEEK WITH 2% W/V CHLORHEXIDINE GULCONATE AND 70% V/V ISOPROPYL ALCOHOL. IT WAS STATED THAT THE HOSPITAL PROCEDURE PROTOCOL FOR A DIALYSIS CATHETER IS TO REPLACE THE CLAMP AND COMPLETE AN INCIDENT REPORT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6692321 ↗