Palindrome 8888145042PRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521158054), received between Nov 27, 2018 and Oct 15, 2025 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, IN THE PATIENT'S FIRST DIALYSIS TREATMENT, THE NURSE NOTICED A SMALL HOLE IN THE VENOUS EXTENSION TUBE LUMEN NEAR THE BIFURCATE HUB. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THE LUMEN WAS FLUSHED PRIOR TO STARTING THE DIALYSIS TREATMENT, AND THE RESULT WAS THE PATIENT DID NOT RECEIVE DIALYSIS UNTIL THE CATHETER WAS REPLACED. IT WAS STATED THAT BECAUSE THE HOLE ALLOWED BLOOD TO EXIT, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW HD (HEMODIALYSIS) CATHETER. BESIDES REMOVING AND REPLACING THE CATHETER, THERE WAS NO OTHER REMEDIAL ACTION DONE AT THE TIME OF THE EVENT. AFTER THE REMEDIAL ACTION WAS DONE, THE TREATMENT WAS CONTINUED AND COMPLETED. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278436 ↗
• InjuryMar 19, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, THE GUIDEWIRE WAS DIFFICULT TO PUSH THROUGH THE PUNCTURE NEEDLE AND TO PULL BACK ONLY WITH MASSIVE FORCE, SO THE WIRE ¿UNTWISTED¿ AND THE CATHETER COULD ONLY BE IMPLANTED WITH ANOTHER GUIDEWIRE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE WITH A NORMAL RESULT. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER GUIDEWIRE. THE GUIDEWIRE USED WAS INCLUDED IN THE KIT. NO REMEDIAL ACTION WAS PERFORMED. THE GUIDEWIRE WAS REMOVED BY FORCEFUL PULLING UNDER X-RAY, AND THEN REMOVAL WITH A PUNCTURE NEEDLE AND A NEW PUNCTURE WAS NECESSARY. IT WAS NECESSARY TO REMOVE THE GUIDE WIRE AND CATHETER FROM THE PATIENT SIMULTANEOUSLY (IN ONE ACTION) DUE TO THE ALLEGED DEFECT. WHEN REMOVED, THE GUIDEWIRE WAS NOT INTACT, AND ALL THE PIECES OF IT WERE TAKEN OUT. NO INTERVENTION/MEDICAL TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT WAS STABLE. THERE WAS NO REPORTED PATIENT IN

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

  MAUDE report 21642598 ↗
• InjuryApr 16, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE SURGICAL INSERTION OF THE CATHETER WORKED WELL. THE SURGEON TESTED THE CATHETER, AND EVERYTHING WAS FINE. THE DIALYSIS PATIENT WITH A PERMANENT LEFT-SIDE JUGULAR CATHETER THEN WENT TO THE HOME HOSPITAL, WHERE THEY PUT ON A COMPETITOR'S STABILIZATION DEVICE FOR THE CATHETER. IT CUT A SMALL HOLE IN THE SILICONE EXTENSION, AND THE STABILIZATION DEVICE DID NOT FIT IN THE CATHETER'S SILICONE EXTENSIONS. THERE WAS A LEAK AT THE JUNCTION OF THE EXTENSION TUBE AND THE BIFURCATE. WHEN CONNECTED, THE NURSE STARTED BY ASPIRATING OUT THE CATHETER LOCK THAT WAS IN THE CATHETER. DURING ASPIRATION, AIR WAS MIXED WITH THE CATHETER LOCK. CONNECTING A NEW SYRINGE: NOW ONLY BLOOD AND NO AIR ASPIRATE. ON CLOSER INSPECTION, A SMALL HOLE WAS SEEN¿DAMAGE TO THE VENOUS STUMP. BY STROKING A STERILE GLOVE OVER THE AREA, TRACES OF BLOOD WERE SEEN ON THE GLOVE BUT NO VISIBLE LEAKAGE BEYOND IT. CHLORHEXIDINE ALCOHOL FRESENIUS KABI CUTANEOUS SOLUTION 5 MG/ML WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED WITH CHLORHEXIDINE ALCOHOL FRESENIUS KABI CUTANEOUS SOLUTION 5 MG/ML PRIOR TO PRODUCT PLACEM

  Patient problems: Hyperkalemia

  MAUDE report 19117464 ↗
• MalfunctionNov 27, 2018Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, DURING TREATMENT, THE FLOW IN THE DIALYSIS LINE COULDN'T BE TAKEN. THE A SIDE AND V SIDE WERE REVERSELY CONNECTED, BUT THE BLOOD REMOVAL FAILED. THE BLOOD REMOVAL FAILURE OCCURRED IN LESS THAN A WEEK AFTER THE CATHETER WAS PLACED AT THE LEFT FEMORAL OF THE PATIENT. IT WAS STATED THAT THE CATHETER COULD BE USED FOR BLOOD RETURN, BUT IT COULDN'T BE USED FOR BLOOD REMOVAL, AND THE A SIDE LINE WAS TAKEN BY DIALYSIS NEEDLE. FLUSHING WAS PERFORMED PRIOR TO USE AND THE DEVICE WAS FLUSHED WITHOUT PROBLEMS. THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8108057 ↗

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-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-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-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-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 33 more.