Palindrome 8888145058PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521158283), received between Dec 8, 2020 and Aug 1, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2022Material Puncture/Hole; Defective Component; Material Puncture/Hole; Defective Component

  ACCORDING TO THE REPORTER, WHEN THE PATIENT WAS SLEEPING AND WOKE UP, IT WAS NOTED THAT THE CVC (CENTRAL VENOUS CATHETER) GAUZE WAS SOAKED IN BLOOD. THE PATIENT WAS PRESENTED TO THE ER (EMERGENCY ROOM) WHERE THE CVC WAS ASSESSED BY THE NEPHROLOGIST. IT WAS NOTED TO BE OOZING FRESH BLOOD FROM THE VENOUS LUMEN, JUST PRIOR TO ITS CONNECTIONS AT THE HUB WHERE THE LUMEN WIDTH INCREASES. THE NEPHROLOGIST STATED WHENEVER THE PATIENT MOVED, OR STOOD UP, THERE WOULD BE FRESH BLOOD LEAKING FROM WHAT APPEARS TO BE A CRACK. THE PATIENT WAS NOT ON DIALYSIS AT THE TIME OF THE INCIDENT SO THE LUMENS WERE LOCKED. THERE WAS A BLOOD LOSS OF APPROXIMATELY 30ML BUT NO BLOOD TRANSFUSION REQUIRED. FLUSHING WAS DONE PRE AND POST TREATMENT. THE CATHETER WAS NOT REPAIRED AND NO LUER ADAPTER ISSUE. WHILE STILL FUNCTIONAL IN THE PATIENT, THE CVC EXIT SITE WAS CLEANSED AND TEGO'S WITH CHG (CHLORHEXIDINE GLUCONATE) WERE UTILIZED. CLAMPS ARE ROTATED UP AND DOWN THE LUMEN EACH TREATMENT. ONCE REMOVED IT WAS WIPED WITH A CAVI WIPE. NO OINTMENT OR CLEANING AGENT USED ON THE CATHETER OR THE SURROUNDING SKIN. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. CVC W

  Patient problems: Air Embolism; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Hemorrhagic Stroke

  MAUDE report 15139331 ↗
• MalfunctionDec 8, 2020Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  ACCORDING TO THE REPORTER, DURING INSERTION ON THE PATIENT, WHEN ATTEMPTING TO PLACE THE GUIDE WIRE THREADS, THE GUIDE WIRE WOULD NOT ADVANCE INSIDE THE PORTION OF THE CATHETER AND IT WAS STUCK. IT WAS NECESSARY TO REMOVE THE GUIDE WIRE TOGETHER (AT THE SAME TIME) WITH THE CATHETER AND WHEN IT WAS REMOVED, IT WAS BENT. THE GUIDE WIRE WAS NOT FRAYED, UNRAVELED, OR COILED. IT WAS NOT NOTICED IN THE PACKAGING OR DURING VISUAL INSPECTION. THE GUIDEWIRE PROVIDED WITH THE KIT WAS BEING USED. NO TOOLS USED WHEN TRYING TO REMOVE THE GUIDEWIRE. NO EXCESSIVE FORCE REQUIRED TO REMOVE THE GUIDEWIRE. THERE WAS A MINIMAL (LESS THAN 5MLS) BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO FLUSHING DONE PRIOR TO USE. THERE WAS NO TEGO UTILIZED AND NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED IODINE WITH PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. A NEW KIT OF THE SAME LOT WAS REQUIRED AND USED. THE PATIENT HAD REINSERTION WITH ANOTHER CATHETER AS INTERVENTION. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 10969038 ↗

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-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-1887-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision SI 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-1885-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision 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-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-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-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.