Palindrome 8888146044PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521158467), received between Apr 14, 2021 and Apr 17, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 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-1312-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2024Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, WHEN THE CATHETER WAS IN THE PATIENT FOR MAYBE 2.5 HOURS, DURING DIALYSIS TREATMENT, THE CATHETER EXPERIENCED A LEAK. THE LEAK WAS SMALL AND SLOW, ESTIMATED AT ONE DROP PER MINUTE. EXACT LOCATION OF THE LEAK WAS UNKNOWN. DIALYSIS WAS NOT ABLE TO BE COMPLETED WITH THE INITIAL CATHETER. DURING THE PLACEMENT OF THE CATHETER, NOTHING UNUSUAL WAS NOTICED. THE CATHETER WAS FLUSHED ON THE BACK TABLE BEFORE INSERTION, AND NO LEAK WAS NOTICED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. WHEN THE PATIENT RETURNED FOR A CATHETER EXCHANGE, NO LEAK WAS VISIBLE. NO OTHER DEFECTS/DAMAGES FOUND WHERE THE LEAK OBSERVED. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NOTHING ELSE UNUSUAL OBSERVED PRIOR TO USE. THE PRODUCT WAS REPLACED, THIS RESOLVED THE ISSUE AND THE TREATMENT WAS COMPLETED. THERE WAS A MINIMAL BLOOD LOSS, ROUGHLY 1 DROP/MINUTE. BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION/TREATMENT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19129086 ↗
• MalfunctionSep 30, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHEN PATIENT ATTENDED IN WARD 215 HDU (HIGH DEPENDENCY UNIT) FOR HEMODIALYSIS AND WHEN LINE LOCKS WERE BEING REMOVED/DRAWN BACK, IT WAS NOTED THAT THERE WAS LEAK FROM A HOLE AT THE VENOUS/BLUE LUMEN NEAR THE BIFURCATE OF THE LINE. TREATMENT WAS STOPPED AND PATIENT WAS FINE. THIS WAS A BRAND NEW LINE. CLINNELL WIPES WAS CLEANING AGENT USED ON THE DEVICE. NO OINTMENT USED. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO FLUSHING DONE PRIOR TO USE. THE LINE WAS IMMEDIATELY CLAMPED, MEDICS INFORMED AND NO FURTHER ISSUES NOTED. THE LINE WAS REPLACED AND THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15520274 ↗
• MalfunctionApr 14, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, APPROXIMATELY 3 HOURS INTO DIALYSIS, THE NURSE NOTED THAT THE CATHETER HAD A HIGH ARTERIAL PRESSURE. AT THIS POINT, THEY TRIED TO FLUSH THE ARTERIAL LUMEN OF THE CATHETER BUT THAT WAS THE TIME WHEN THE CATHETER WAS RUPTURED. IT WAS ALSO STATED THAT THEY WERE ABLE TO APPLY QUICKLY THE BLUE CLAMP ABOVE THE RUPTURED PART OF THE CATHETER. THE PATIENT WAS TAKEN TO THE RADIOLOGY FOR URGENT REWIRE AND THE LARGE TEAR BETWEEN THE CLAMP CAN BE VISUALIZED. THE CATHETER WAS NOT REPAIRED, THERE WAS A LEAK AT THE MIDDLE OF THE EXTENSION TUBE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 11665419 ↗

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-1887-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision SI 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-1888-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• 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-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-1313-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
• 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-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
• 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-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

…and 33 more.