Palindrome 8888541044PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521158535), received between Nov 27, 2017 and Feb 23, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

49 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.

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.

• MalfunctionFeb 23, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING THE REPORTER, DURING PROCEDURE, BLOOD LEAK WAS OBSERVED AT THE CRACK NOTED IN THE EXTENSION TUBE (BLUE). THE CATHETER WAS REPAIRED WITH A REPAIR KIT, IT RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED. NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. TEGO WAS NOT UTILIZED. NO PHYSICAL LUER ADAPTER DAMAGE WAS OBSERVED. 2% CHLORHEXIDINE WAS USED ON THE DEVICE/ADAPTERS AS CLEANING AGENT AND WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CLAMPS WERE MOVED TO A NEW LOCATION AFTER EACH TREATMENT. NOTHING UNUSUAL OBSERVED PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS AN UNMEASURED BLOOD DROPLET BUT NO BLOOD TRANSFUSION WAS REQUIRED. NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364674 ↗
• MalfunctionFeb 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE, WHEN THE NURSE REMOVED THE DRESSING BEFORE DIALYSIS, THE HUB WAS FOUND TO BE LOOSE (NOT TIGHT), THE Y PART WAS ALMOST DETACHED AND WAS NOT COMPLETELY DISENGAGED FROM THE CATHETER SHAFT. A DOCTOR WAS INFORMED AND HE OPENED A NEW CATHETER OF THE SAME TYPE AND TOOK OUT THE HUB AND HUB ASSEMBLY FOR USE (HUB AND Y PARTS). IT WAS ALSO STATED THAT THE LUER ADAPTER WAS DETACHED. IT WAS REPORTED THAT THERE WAS NO BLOOD LOSS FROM THE EVENT. IT WAS REPORTED THAT THE CATHETER WAS REPAIRED, THERE WAS NO LEAK, 70% ALCOHOL WAS THE CLEANING AGENT USED. IT WAS STATED THAT THE DRESSING USED DOES NOT INCLUDE ANY CLEANING AGENTS OR ANTI MICROBIAL PROPERTIES AND THE CLEANING AGENTS ARE ALLOWED TO DRY THOROUGHLY PRIOR TO DRESSING AND APPLYING OINTMENTS TO THE AREA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771262 ↗
• MalfunctionNov 27, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THERE WAS A HOLE IN THE CATHETER. THE CATHETER COULD NOT BE USED AND WAS REPLACED.

  Patient problems: No Information

  MAUDE report 7061350 ↗

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-1887-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision SI 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-1888-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• 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-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-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-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-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-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-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-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-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 34 more.