Palindrome 8888145044PRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521158092), received between Jun 12, 2017 and Mar 26, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

48 other recalls cover devices cleared under the same FDA submission (K123196); 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 18, 2026.

Recalls naming this device

1. Jun 8, 2022Class IOpen, Classified

   There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

   Z-1313-2022 · Root cause: Process control · Recall details · FDA record ↗

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 26, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHEN CHECKING FOR IMPERMEABILITY OF THE CATHETER, BLOOD WAS LEAKING AT THE DISTAL JUNCTION BETWEEN THE RED TIP AND THE CLEAR (WHITE) TUBING. CATHETER WAS REPAIRED USING A REPAIR KIT IN ORDER TO RESOLVE THE ISSUE. CHLOREXIDINE SWABS WERE USED AS CLEANING AGENT. THERE WAS NO NOTED AMOUNT OF BLOOD LEAK (ML). IT WAS ALSO REPORTED THAT HEMOCULTURE WAS DONE AND WAS GIVEN ANTIBIOTICS AT END OF TREATMENT CLOSING BOTH LINES WITH ANTIBIOTIC (ANTIBIOTIC LOCK). THERE WAS REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8453818 ↗
• MalfunctionJan 31, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, DURING TREATMENT, BLOOD LEAK WAS NOTED COMING FROM THE DISTAL JUNCTION OF THE VENOUS BRANCH. IT WAS STATED THAT THERE WAS A BREAK AT THIS PLACE. TREATMENT WAS NOT INITIATED AS THERE WAS A RISK OF AIR ENTERING THE LEAK AND PULMONARY EMBOLISM. THE VENOUS BRANCH WAS REPAIRED WITH THE REPAIR KIT AND A DOSE OF ANTIBIOTICS WAS GIVEN AS AN INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8293615 ↗
• MalfunctionJan 31, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, DURING TREATMENT, BLOOD LEAK WAS NOTED COMING FROM THE DISTAL JUNCTION OF THE VENOUS BRANCH. IT WAS STATED THAT THERE WAS A BREAK AT THIS PLACE. TREATMENT WAS NOT INITIATED AS THERE WAS A RISK OF AIR ENTERING THE LEAK AND PULMONARY EMBOLISM. THE VENOUS BRANCH WAS REPAIRED WITH THE REPAIR KIT AND A DOSE OF ANTIBIOTICS WAS GIVEN AS AN INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8293613 ↗
• MalfunctionJan 31, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, DURING TREATMENT, BLOOD LEAK WAS NOTED COMING FROM THE CONNECTION OF THE ARTERIAL (RED) CONNECTOR AND THE EXTENSION TUBE. THEN AFTER A FEW WEEKS, WHILE CHECKING FOR PERMEABILITY OF THE CATHETER, THE VENOUS (BLUE) HAD THE SAME ISSUE. IT WAS STATED THAT THE CONNECTOR WAS CHANGED WITH THE REPAIR KIT, DISTAL CONNECTORS WERE CHANGED AND IV ANTIBIOTICS WAS GIVEN AS AN INTERVENTION. IT WAS STATED THAT CATHETER WAS 1 YEAR OLD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8293496 ↗
• MalfunctionJan 31, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, DURING TREATMENT, BLOOD LEAK WAS NOTED COMING FROM THE CONNECTION OF THE ARTERIAL (RED) CONNECTOR AND THE EXTENSION TUBE. THEN AFTER A FEW WEEKS, WHILE CHECKING FOR PERMEABILITY OF THE CATHETER, THE VENOUS (BLUE) HAD THE SAME ISSUE. IT WAS STATED THAT THE CONNECTOR WAS CHANGED WITH THE REPAIR KIT, DISTAL CONNECTORS WERE CHANGED AND IV ANTIBIOTICS WAS GIVEN AS AN INTERVENTION. IT WAS STATED THAT CATHETER WAS 1 YEAR OLD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8293455 ↗
• MalfunctionJan 4, 2018Hole In Material; Hole In Material

  ACCORDING TO THE REPORTER, THE NURSE WAS FLUSHING THE CATHETER WITH NORMAL SALINE AND NOTICED A TEAR IN THE CATHETER BETWEEN THE ARTERIAL CONNECTOR AND THE SILICONE EXTENSION. THE WHITE PLASTIC WRAP AROUND THE SILICONE TUBE ARTERIAL CONNECTOR WAS LOOSE AND COULD BE ROTATED 360 DEGREES. THE CATHETER WAS REPLACED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7166480 ↗
• MalfunctionSep 8, 2017Hole In Material; Hole In Material

  THE CUSTOMER STATES DURING HEMODIALYSIS THEY FOUND A HOLE IN THE CATHETER WHERE THE VENOUS LUER CONNECTOR JOINS THE SILICONE EXTENSION. THE CATHETER WAS REPLACED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6852050 ↗
• MalfunctionJun 12, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THERE IS A LEAK IN THE CATHETER UNDER THE LUER CONNECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6633276 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123196. One submission often covers many models, so check the product and lot details in each record.

• Z-1886-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1889-2025 · Apr 23, 2025 · Open, Classified
  MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1885-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1887-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1888-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1635-2024 · Mar 15, 2024 · Open, Classified
  Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, aph
• Z-1634-2024 · Mar 15, 2024 · Open, Classified
  Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute a
• Z-1315-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-1314-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
• Z-1312-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
• Z-2375-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
• Z-2371-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
• Z-2374-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
• Z-2373-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
• Z-2372-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P

…and 33 more.