Palindrome 8888145017PRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521158009), received between May 26, 2023 and Nov 12, 2024 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 8, 2022Open, 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 · 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.

• InjuryNov 12, 2024Migration; Migration

  ACCORDING TO THE REPORTER, A PATIENT WITH TYPE II DIABETES, HYPERTENSION, PERIPHERAL VASCULAR DISEASE, AND LEFT BELOW KNEE AND RIGHT FOREARM AMPUTATIONS DUE TO DIABETIC WOUND INFECTIONS, WITH MULTIPLE ISSUES WITH VASCULAR ACCESS IN THE PAST, MULTIPLE STAPHYLOCOCCUS AUREUS INFECTIONS AND COLONIZATION HAD BEEN ON LONG-TERM DALBAVANCIN SINCE MID-FEBRUARY AND REQUIRED MULTIPLE COURSES OF VANCOMYCIN ON TOP OF THIS IN ORDER TO CONTROL INFECTION OF ARTERIOVENOUS (AV) GRAFTS. RECENT EXPLANTATION OF INFECTED AV GRAFT IN RIGHT UPPER ARM (MID (B)(6)); DALBAVANCIN STOPPED AFTER THIS. ON THE (B)(6), THE 33 CM (CENTIMETERS) LINE WAS PROBLEMATIC WITH POOR FLOWS. THE REASON WAS THAT THE LINE DISPLACED AT THAT TIME, ALTHOUGH NOT NOTICED AT THE TIME. THEY REQUESTED A LINE EXCHANGE. ON THE (B)(6) 2024, THE LINE CUFF WAS NOTED TO BE MIGRATED OUT OF THE EXIT SITE OF THE TUNNELED LINE, ALTHOUGH IT APPEARED TO BE HEALING ONTO THE OUTSIDE OF THE EXIT SITE. IT WAS SEEN BY THE VASCULAR NURSE WHO AWAITED TO GET FURTHER ADVICE FROM MEDICAL STAFF. BOTH LUMENS FLOW CHECKED, AND THE ARTERIAL LUMEN WAS SLIGHTLY STICKY. BLOODS SENT AS URGENT AND LINE LOCKED WITH HEPARIN. THE HOSPITAL WAS ALERTED BY NURSING STAFF T

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hyperkalemia; Peripheral Edema

  MAUDE report 20669243 ↗
• MalfunctionNov 12, 2024Migration; Migration

  ACCORDING TO THE REPORTER, WHILE THE PATIENT WAS AT HOME, THE THIRD LINE CAME OUT COMPLETELY. THE PATIENT WOULD BE COMING TO THE HOSPITAL THE NEXT DAY FOR REVIEW AS THE SITE WAS NOT BLEEDING AND THE PATIENT HAD A FULL DIALYSIS SESSION THE PREVIOUS DAY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20666299 ↗
• MalfunctionJul 23, 2024Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, A PATIENT WITH POLYCYSTIC KIDNEY DISEASE, HYPERTENSION, AND END-STAGE RENAL FAILURE NOTICED A STITCH THAT CAME LOOSE AT HOME. LITERALLY ALL THAT WAS DOCUMENTED WAS THAT THE PATIENT SAID THE STITCH HAD COME LOOSE. THEY WOULD ASSUME THAT IF ANY PART OF THE SECUREMENT WING HAD BROKEN OR BEEN FOUND FAULTY, THE NURSING STAFF WOULD HAVE DOCUMENTED THIS AND CALLED THE PARENT WARD FOR ADVICE. STANDARD CLEANING OF DIALYSIS CATHETERS WAS WITH GREEN CLINELL DEVICE WIPES, 2% CHLORHEXIDINE, 70% ALCOHOL, AND BD CHLORAPREP ON DRESSING CHANGE DAYS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19805220 ↗
• InjuryJul 18, 2024Migration; Migration

  ACCORDING TO THE REPORTER, A PATIENT WITH POLYCYSTIC KIDNEY DISEASE, HYPERTENSION, AND END-STAGE RENAL FAILURE WAS PRESENTED TO THE PERIPHERAL DIALYSIS UNIT FOR USUAL DIALYSIS; THE CUFF WAS NOTED TO BE OUT 2.5 CM (CENTIMETER). THE LINE HAD MOVED OUT AND THE CUFF WAS FULLY VISIBLE. THEY CONTACTED THE RENAL REGISTRAR, WHO ADVISED THE PATIENT TO ATTEND ARI (ACUTE RESPIRATORY INFECTION) WARD 108 FOR REVIEW. THE PATIENT WAS SENT TO THE MAIN HOSPITAL FOR FURTHER ASSESSMENT AS REMEDIAL ACTION. PATIENT WAS UNABLE TO TRANSPORT BY THEMSELVES; A TAXI WAS ARRANGED TO TAKE THE PATIENT TO ARI. SBAR (SITUATION, BACKGROUND, ASSESSMENT, AND RECOMMENDATION) COMPLETED AND GIVEN TO PATIENT. THEY ENSURED THAT THE LINE FELT SECURE BEFORE LEAVING THE UNIT, THE LINE WAS SECURED WITH EXTRA DRESSINGS AND THE PATIENT HAD EXTRA GAUZE WITH THE PATIENT. HEMODIALYSIS WAS ATTEMPTED IN THE HOSPITAL, BUT THE PATIENT REPORTED PAIN FROM THE ENTRY ACCESS SITE DOWN TO THE SHOULDER ONE HOUR INTO DIALYSIS AND WAS UNABLE TO CONTINUE AFTER THE CIRCUIT WAS THEN CLOTTED. MEDICAL STAFF PHONED AND BY THE TIME, THEY HAD ANSWER, LINE WAS CLOTTED, THE DIALYSIS ATTEMPT WAS ABANDONED. GENERALLY, WHEN THE NURSES SAY THE LINE WAS CLO

  Patient problems: Pain

  MAUDE report 19774662 ↗
• InjuryMay 17, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE PATIENT HAD A LIVER TRANSPLANT, LONG-TERM STEROIDS FROM PREVIOUS REJECTION, CALCIPHYLAXIS, WAS TYPE TWO DIABETIC, HAD BEEN ON INSULIN TREATMENT FOR 5¿6 YEARS, AND HAD CHRONIC KIDNEY DISEASE G5. ON HEMODIALYSIS THREE TIMES A WEEK, HYPERTENSION AND DYSLIPIDEMIA. WHEN THE PATIENT ATTENDED THE DIALYSIS TREATMENT, A SMALL HOLE IN THE ARTERIAL LUMEN BELOW THE BIFURCATION LINE WAS NOTED. LINE EXAMINED UPON REMOVAL AND DOCUMENTED AS SMALL LEAK DEMONSTRATED AT CLAMPING POINT OF RED LUMEN. FLUSHING WAS DONE WITH SALINE PRIOR TO INSERTION AND THE RESULT WAS NORMAL. THE CATHETER WAS NOT REPAIRED, THERE WAS A LEAK AT THE BIFURCATE, AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WAS NOTHING UNUSUAL OBSERVE ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. 2% CHLORHEXIDINE IN 70% ALCOHOL WAS THE CLEANING AGENT USED ON THE DEVICE. CHLORHEXIDINE WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. DIALYSIS COULD NOT BE COMPLETED WITH AFFECTED LINE. AS MEDICAL INTERVENTION, THE REPORT

  Patient problems: Unspecified Infection

  MAUDE report 19341256 ↗
• InjuryJan 19, 2024Material Puncture/Hole; Insufficient Flow or Under Infusion; Material Puncture/Hole; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE CATHETER HAD BEEN IMPLANTED INTO THE PATIENT FOR 1 DAY. HOLE WAS FOUND IN BOTH LUMENS OF THE THE SILICONE EXTENSION TUBE AND BLOOD LEAKAGE WAS FOUND IN IT. THE DOCTOR SAID THAT CLAMPS WERE PLACED NEAR THE BIFURCATE AND TRIED TO FLUSH LUMENS AGAINST RESISTANCE, BOTH LUMENS GOT HOLES. THEY WERE NOT VISIBLE UNLESS IT WAS FLUSHED AGAINST RESISTANCE (OR HIGH PRESSURE SUCH AS ON HDF). CLAMP APPLIED ABOVE HOLES AREA. HOLES WERE TOO HIGH FOR REPAIR KIT TO BE USED. THERE WAS NO LUER ADAPTER ISSUE AND THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS TREATED WITH CHLORHEXIDINE PRIOR TO PRODUCT PLACEMENT. THE UNUSUAL OBSERVED WAS INITIALLY, THEY ATTEMPTED TO DIALYZE AT SATELLITE UNIT; FLUSHING WAS DONE AND AS A RESULT POOR FLOWS SO UROKINASE LUMEN DWELL FOR ONE HOUR AS PER PROTOCOL, AT THIS POINT SMALL HOLE NOTED IN VENOUS LUMEN, THEN TRANSFERRED TO ROYAL. THE LINES WERE THEN RE-EXAMINED AND HOLES TO BOTH VENOUS AND ARTERIAL LUMENS NOTED. UROKINASE WAS THE OTHER PRODUCT UTILIZED AND ONLY USED FOR H EMODIALYSIS. THE CATHETER USED WAS 14.5 FR. (FRENCH) WITH 33 CENTIMETER. THE CLAMP WAS FIRST TIME USED. THE LINE COULD NOT BE USED FOR DIALYSIS A

  Patient problems: Insufficient Information

  MAUDE report 18545480 ↗
• MalfunctionJan 19, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, 2 DAYS AFTER POST PLACEMENT AND ATTEMPTED TO USE THE LINE FOR DIALYSIS, A HOLE WAS FOUND IN THE VENOUS SIDE OF THE SILICONE EXTENSION TUBE (EXTERNAL PORTION) AND BLOOD LEAKAGE WAS FOUND IN IT. THERE WAS NO LUER ADAPTER ISSUE AND THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS TREATED WITH CHLORHEXIDINE PRIOR TO PRODUCT PLACEMENT. THE CATHETER USED WAS 14.5 FR. (FRENCH) WITH 33 CENTIMETER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. FLUSHING WAS ALWAYS DONE BY USING SALINE IN PRE-HEMODIALYSIS TREATMENT AND AS A RESULT A HOLE WAS DETECTED AND VENOUS LUMEN WAS NOT USED. THE CLAMP WAS USED FOR THE FIRST TIME. THE LINE COULD NOT BE USED FOR DIALYSIS AND REQUIRED REPLACEMENT, WHICH WAS ANOTHER SIGNIFICANT PROCEDURE FOR THE PATIENT. TO RESOLVE THE ISSUE, THE LINE WAS REMOVED AND NOT REPLACED AS FOR PATIENT'S REQUEST. THERE WERE NO CURRENT AND PRE-EXISTING CONDITIONS OF THE PATIENT THAT MAY BE RELATED TO THE EVENT. BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT REFUSED FURTHER INTERVENTION AND CHOSE END-OF-LIFE CARE ONLY. DIALYSIS WAS PREVENTED. THERE WAS NO REPO

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545100 ↗
• MalfunctionMay 26, 2023Migration; Migration

  ACCORDING TO THE REPORTER, THE CATHETER'S LINE FELL OUT. THE LINE CUFF WAS OUT. WHEN THE SHOWER POUCH ON TOP OF THE LINE EXIT SITE DRESSING WAS REMOVED IT PULLED (NOT TOTALLY OUT, HOWEVER, THE CUFF WAS OUT). THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 17014922 ↗

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-1889-2025 · Apr 23, 2025 · Open, Classified
  MAHURKAR 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-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-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-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-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-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-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-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

…and 33 more.