EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet 5913190Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741013836), received between Apr 16, 2019 and Mar 24, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Defective Component” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT FOUR MONTHS AND EIGHTEEN DAYS POST INDEX PROCEDURE COMPLETION, THE SUBJECT HAD ADVERSE EVENT OF CLOTTED CATHETER. IT WAS FURTHER REPORTED THAT, THE ADVERSE EVENT RELATIONSHIP TO STUDY DEVICE WAS POSSIBLY RELATED AND THUS THE ACTION WAS TAKEN TO REMOVE THE DEVICE. REPORTEDLY, THE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED EXCHANGING ANOTHER NEW CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610895 ↗
• InjuryMar 24, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT NINE MONTHS AND TWENTY-SIX DAYS POST INDEX PROCEDURE COMPLETION, THE SUBJECT HAD ADVERSE EVENT OBSTRUCTED CATHETER WITH FIBRIN SHEATH FORMATION. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT RELATIONSHIP TO STUDY DEVICE WAS POSSIBLY RELATED WHICH REQUIRES ADDITIONAL SURGICAL INTERVENTION AND SO ACTION WAS TAKEN TO REMOVE THE DEVICE. REPORTEDLY, THE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED EXCHANGING ANOTHER NEW CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 16609195 ↗
• MalfunctionJan 23, 2021Malposition of Device; Patient Device Interaction Problem; Malposition of Device; Patient Device Interaction Problem

  THIS REPORT SUMMARIZES FOUR MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DL900J VENA CAVA FILTER ALLEGEDLY EXPERIENCED PERFORATION AND TILT. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE FOUR MALFUNCTIONS INVOLVED PATIENTS WITH NO CONSEQUENCES. OF THE FOUR MALFUNCTIONS, ONE MALE AND THREE FEMALES AGES WERE REPORTED RANGING FROM 44 TO 77. THE WEIGHT OF ONE PATIENT WAS (B)(6) KGS AND THE REMAINING PATIENT WEIGHTS ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11219798 ↗
• MalfunctionJun 6, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING THE PLACEMENT OF THE DIALYSIS CATHETER, THE DILATOR ALLEGEDLY BROKE WHEN ATTEMPTING TO TAKE THE INNER STYLET OUT. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675756 ↗
• MalfunctionMay 7, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE THE TIP OF THE TUNNELER WAS ALLEGEDLY BROKEN. REPORTEDLY, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8587111 ↗
• MalfunctionApr 25, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE THE BLUE PART OF THE TUNNELER WAS ALLEGEDLY BROKEN. REPORTEDLY, A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8550274 ↗
• MalfunctionApr 18, 2019Component Incompatible; Component Missing; Component Incompatible; Component Missing

  IT WAS REPORTED THAT DURING PREPARATION FOR THE CHRONIC CATHETER PLACEMENT, TWO KITS WERE OPENED AND THE PEEL-AWAY SHEATHS WERE ALLEGEDLY INCOMPATIBLE FOR THE PACKAGED CATHETER AND WERE RENDERED UNUSABLE. REPORTEDLY, ANOTHER TWO KITS WERE UNOPENED AND THE INCORRECT SIZE WAS ALLEGEDLY ABLE TO BE IDENTIFIED THROUGH THE CLEAR PACKAGING, THEREFORE, THE CUSTOMER ALLEGED THE FOUR KITS WERE PROVIDED WITH THE INCORRECT SIZE SHEATH. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS IMPLANTED. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8528525 ↗
• MalfunctionApr 16, 2019Obstruction of Flow; Malposition of Device; Obstruction of Flow; Malposition of Device

  THIS REPORT SUMMARIZES THREE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL EC500F ECLIPSE FILTER SYSTEM EXPERIENCED A MALPOSITION OF DEVICE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL THREE EVENTS HAD NO REPORTED PATIENT INJURY. OF THE THREE REPORTED PATIENT, 2 PATIENTS WERE MALE, ONE PATIENT WEIGHT WAS 267 LBS; HOWEVER, OTHER PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8521072 ↗