Palindrome 8888541028PRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521158511), received between Jun 15, 2017 and Dec 6, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, ON (B)(6) 2021, THE CATHETER WAS PLACED SUCCESSFULLY AND SO WERE THE FIRST COUPLE OF DIALYSIS SESSIONS. ON (B)(6), 2021, DURING DIALYSIS, THERE WAS A LEAKAGE DETECTED AT THE PLACE WHERE THE TWO CATHETER PARTS/SIDES WERE CLICKED TOGETHER - LEAK BETWEEN TWO WHITE PIECES. THE CATHETER WAS REPAIRED. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NO DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED (CRACK, CUT, ETC.). IODIUM ALCOHOL AND STERILE DRAPES WERE USED TO TREAT THE INSERTION SITE DURING DIALYSIS. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE (CLEANING, DRESSING CHANGES, ETC.) AND THE PATIENT WAS NOT USING ANY TYPE OF CLEANING AGENT OR ANTIBIOTIC ON THE CATHETER AS THESE WERE BOTH BEING DONE BY NURSES. IT WAS SAID THAT THERE WAS AN UNSPECIFIED AMOUNT OF BLOOD LOSS DURING DIALYSIS. THE CATHETER WAS ONLY REPAIRED A COUPLE OF DAYS LATER, WITH A SIMILAR CATHETER (SAME PRODUCT ID AND LOT NUMBER). IT WAS SAID THAT THE DIALYSIS WAS ONLY RESTARTED WHEN THE CATHETER WAS REPAIRED, NOTHING UNUSUAL WAS OBSERVED AND TREATMENT WAS SAID TO BE C OMPLETED. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933622 ↗
• MalfunctionApr 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, A DAY AFTER ITS INSERTION, THE CATHETER BROKE APART AT THE JUNCTION BETWEEN THE MAIN BRANCH AND THE 2 SMALLER BRANCHES (COMPLETE DETACHING). IT WAS ALSO STATED THAT A CRACK WAS FOUND IN THE SAME PLACE DURING A DRESSING CHANGE. IT WAS REPORTED THAT THERE WAS A STAFF MEMBER WHO ATTENDED THE EVENT WHICH ALLOWED FOR PROMPT TREATMENT/RESPONSE. ALSO, THE DOCTOR WAS NOTIFIED BY THE BEDSIDE-NURSE REGARDING THE CATHETER DISCONNECTION AND WHEN THE DOCTOR ARRIVED AT THE PATIENT'S BEDSIDE, NO BLOOD LOSS WAS NOTED OTHER THAN A SMALL AMOUNT OF DRY BLOOD (SLIGHT DRY BLEEDING - NO ACTIVE BLEEDING). THE PHYSICIAN HAD NO ADDITIONAL INFORMATION RELATED TO REASONS FOR LACK OF BLOOD LOSS FROM THE CATHETER. THE CATHETER REMAINED SUTURED AT THE HUB AND THE CATHETER WAS CLAMPED BY THE PHYSICIAN AT THAT TIME. ADDITIONALLY, IT WAS SAID THAT DURING CATHETER IMPLANTATION, THE CATHETER WAS FULLY ADVANCED THROUGHTHE LOCKING RING AND FULLY PRESSED AGAINST THE HUB. ALSO, ACCORDING TO THE INSERTION CLINICIAN, THE CATHETER WAS NOT CONNECTED TO THE HUB CORRECTLY SO THEY INVERTED STEP #18 AND #19 BUT HAD DIFFICULTY TO PUSH THE CATHETER ALL THE WAY THROUGH. HOWEVER, THE HUB CONNECTOR DID CLI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613832 ↗
• MalfunctionSep 28, 2020Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE CATHETER WAS IMPLANTED AND 20 DAYS AFTER, BEFORE THE DIALYSIS TREATMENT, THE DIALYSIS SPECIALIST FOUND THE VENOUS (BLUE) CONNECTOR TO BE BROKEN (HAD A BIG CRACK). THE DOCTOR WAS INFORMED AND THE DIALYSIS WAS STILL PERFORMED DESPITE THE CRACK AND WENT WITHOUT PROBLEMS. THE CATHETER WAS STILL USED SUCCESSFULLY THE TREATMENT WAS COMPLETED. THERE WAS NO LEAK AND THE CLEANING AGENTS USED WERE SODIUM CHLORIDE (NACL) 0.9% FOR THE CONNECTORS AND OCTENISEPT ALCOHOL-FREE FOR THE EXIT SITE. OCTENISEPT ALCOHOL-FREE AS ALSO USED TO CLEAN THE CATHETER AND THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. TEGO WAS NOT UTILIZED. THE ADAPTERS WERE TIGHTENED MANUALLY. FLUSHING WAS DONE AND EVERYTHING WAS NORMAL, FLUID FLOW WAS NORMAL. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. AFTERWARDS ON THE SAME DAY, THE CATHETER WAS REPAIRED WITH A REPAIR KIT. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10597293 ↗
• MalfunctionJul 2, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, A HAIR CRACK WAS OBSERVED ON THE EXIT SITE OF RED EXTENSION TUBE WHICH HAD CAUSE THE LEAKAGE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. "OCTENISEPT" WAS THE CLEANING AGENT USED ON THE DEVICE. CLAMPS WERE MOVED TO A NEW LOCATION AFTER EACH TREATMENT. IT WAS MENTIONED THAT ONLY A FEW DROPS OF BLOOD WERE SEEN FROM THE HAIR CRACK, NO BLOOD LOSS DURING REPLACEMENT AND AFTER THE TREATMENT. BLOOD TRANSFUSION WAS NOT REQUIRED. IT WAS STATED THAT THE CATHETER WAS REPLACED WITH A NEW ONE AND FOUND NO ISSUE LIKE HAIR CRACK. IT WAS REPORTED THAT DURING THE CATHETER REPLACEMENT, THERE WAS NOTHING UNUSUAL OBSERVED PRIOR TO INSERTION AND THE CATHETER WAS FLUSHED WITH SALINE AND THE END WAS BLOCKED WITH HEPARIN. THE ISSUE WAS RESOLVED THROUGH CATHETER REPLACEMENT AS INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10226132 ↗
• MalfunctionJan 30, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, AFTER THE PATIENT WAS DISCONNECTED FROM THE MACHINE, THERE WAS A MICRO HOLE ON THE EXTENSION TUBE (RIGHT JUGULAR). IT WAS ALSO STATED THAT THEY REPLACED THE PART THE THAT WAS FISSURED. CLOREXIDINA WAS USED ON THE DEVICE AS CLEANING AGENT AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. TEGO WAS NOT UTILIZED AND THERE WAS NO LEUR ADAPTER ISSUE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS ALSO NOTED THAT THE CLAMP WAS MOVED PERIODICALLY AND APPROXIMATELY 2ML (MILLILITERS) OF BLOOD LOSS. THEY SIMPLY APPLIED THE KIT AND ELIMINATE THE DAMAGED PART AS MEDICAL INTERVENTION DONE TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9646888 ↗
• MalfunctionMay 24, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, THEY SAW AIR BUBBLES IN THE ARTERIAL EXTENSION APPROXIMATELY HALF A CENTIMETER AFTER THE BIFURCATE. DIALYSIS TREATMENT WAS STOPPED, THEY STUCK A PLASTER AROUND THE EXTENSION AS AN INTERVENTION AND SENT THE PATIENT TO THE DOCTOR. IT WAS STATED THAT FLUSHING WAS DONE PRIOR TO TREATMENT AND THEY DID NOT SEE ANYTHING AND IT WAS STATED THAT THE CLAMPS ARE NOT MOVED TO A NEW LOCATION AFTER EACH TREATMENT. THE CATHETER WAS CHECKED AND AFTER CHECKING THEY DECIDED TO REMOVE THE CATHETER (CATHETER HAS BEEN IN PLACE FOR 14 DAYS) AND INSERTED A NEW ONE. THERE WAS NO OTHER PRODUCT BEING USED WITH THE DEVICE. THE CATHETER WAS NOT REPAIRED, IT WAS STATED THAT THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND OCTENISEPT WAS THE CLEANING AGENT USED. THERE WAS BLOOD LOSS OF LESS THAN 1ML. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8640682 ↗
• MalfunctionJan 9, 2019Crack; Crack

  ACCORDING TO THE REPORTER, DURING USE, IT WAS NOTED THAT THE BLUE (VENOUS) LUER ADAPTER HAD HAIRLINE CRACKS AND HAD A LEAK. IT WAS STATED THAT THE CATHETER WAS INITIALLY REPAIRED WITH A REPAIR KIT, NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE, ALCOHOL-FREE WERE USED AS CLEANING AGENTS. IT WAS ALSO STATED THAT CLEANING AGENTS ARE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENTS ON THE AREA, PRIOR TO DRESSING THE AREA, AND PATIENTS ARE NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE, CLEANING AGENTS WERE NOT SWITCHED OVER THE LIE OF THE CATHETER, CLEANING AGENTS WERE NOT MIXED AND THE SAME CLEANING AGENTS ARE ALWAYS USED. TREATMENT CONTINUES WITH THE REPAIRED CATHETER AND THE DAMAGED/CRACKED LUER ADAPTERS WERE DISCARDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8231756 ↗
• MalfunctionJan 8, 2019Crack; Crack

  ACCORDING TO THE REPORTER, DURING USE, IT WAS NOTED THAT THE BLUE (VENOUS) LUER ADAPTER HAD HAIRLINE CRACKS AND HAD A LEAK. IT WAS STATED THAT THE CATHETER WAS INITIALLY REPAIRED WITH A REPAIR KIT. CODAN AND OCTINISEPT ALCOHOL-FREE WERE THE CLEANING AGENTS USED. TREATMENT CONTINUES WITH THE REPAIRED CATHETER AND THE DAMAGED/CRACKED LUER ADAPTERS WERE DISCARDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8228228 ↗
• MalfunctionJan 8, 2019Crack; Crack

  ACCORDING TO THE REPORTER, DURING USE, IT WAS NOTED THAT THE BLUE (VENOUS) LUER ADAPTER HAD HAIRLINE CRACKS AND HAD A LEAK. IT WAS STATED THAT THE CATHETER WAS INITIALLY REPAIRED WITH A REPAIR KIT. CODAN AND OCTINISEPT ALCOHOL-FREE WERE THE CLEANING AGENTS USED. TREATMENT CONTINUES WITH THE REPAIRED CATHETER AND THE DAMAGED/CRACKED LUER ADAPTERS WERE DISCARDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8228161 ↗
• MalfunctionOct 18, 2018Break; Break

  ACCORDING TO THE REPORTER, BEFORE DIALYSIS, AFTER THE DRESSING HAD BEEN REMOVED, THE CATHETER SHAFT THAT IS LINKED TO THE HUB WAS DETACHED. THE CATHETER WAS REPAIRED TO RESOLVE THE ISSUE. IT WAS ALSO STATED THAT THE CATHETER WAS USED FOR ABOUT TWO MONTHS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7979781 ↗
• MalfunctionOct 16, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE, WHEN REMOVING THE PROTECTIVE BANDAGE BEFORE STARTING DIALYSIS, THE ATRIAL CATHETER SHAFT DISCONNECTED FROM THE (PUSH-IN) FIXED Y-PIECE. ONLY A QUICK DISCONNECTION OF THE RESIDUAL CATHETER PREVENTED A MORE SERIOUS COMPLICATION (E. G. AIR EMBOLISM/BLOOD LOSS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7971325 ↗
• MalfunctionJun 21, 2018Break; Material Puncture/Hole; Break; Material Puncture/Hole

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, AFTER OPENING THE CATHETER BEFORE STARTING DIALYSIS, TWO CRACKS (ACROSS AND ALONG) WERE OBSERVED ON THE DEVICE'S VENOUS EXTENSION TUBE. IT WAS STATED THAT THE OUTER PARTS OF THE CATHETER WERE REPAIRED BY USING ANOTHER KIT OF CATHETER. THE DEVICE WAS INSERTED ON (B)(6) 2018 AND HAS BEEN IN PLACE FOR 10 DAYS. IT WAS ALSO STATED THAT THE CLAMPS WERE MOVED TO A NEW LOCATION AFTER EACH TREATMENT AND FLUID WAS NOT PUSHED BY SYRINGE TO THE CLOSED CLAMP BEFORE SEEING THE CRACKS. THE CATHETER WAS BLOCKED WITH THE CLEANING AGENT. ONLY BLOODLINES WERE UTILIZED WITH THE DEVICE AND THE ADAPTERS WERE TIGHTENED BY HAND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7624667 ↗
• MalfunctionJun 15, 2017Break; Break

  IT WAS REPORTED TO COVIDIEN ON (B)(6)2017 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE DILATOR BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Information

  MAUDE report 6645043 ↗

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-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-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-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-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-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-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-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-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

…and 34 more.