Palindrome 8888145049CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521158160), received between Dec 21, 2018 and Nov 8, 2022 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device 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-1315-2022 · 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.

• InjuryNov 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE CATHETER HAD BEEN IMPLANTED IN THE PATIENT FOR ABOUT 2 YEARS AND 3 MONTHS. WHEN AT HOME, IT WAS FOUND THAT THE VENOUS LUER ADAPTER (BLUE LUMEN) WAS MISSING FROM THE END OF THE LINE OR IT FELL OUT AND PATIENT HAD BEEN ADMITTED OVER THE WEEKEND DUE TO THE REPORTED ISSUE. THE CATHETER WAS COMPROMISED TO INFECTION/AIR EMBOLISM/BLOOD LOSS. THERE WAS NO EVIDENCE OF LEAK AND IT WAS NOT CONFIRMED. THERE WERE NO DEFECTS/DAMAGES FOUND ON THE DEVICE AND NO OTHER PRODUCTS WERE UTILIZED. IT WAS ALSO STATED THAT FLUSHING WAS NOT PERFORMED BECAUSE IT WAS UNSAFE DUE TO BEING UNABLE TO ATTACH THE SYRINGE AND CLINELL WIPES WAS THE CLEANING AGENT USED ON THE DEVICE. IT WAS UNSURE EXACTLY HOW THIS HAPPENED TO FRAIL PATIENT AND THEY WERE NOT SURE IF THE PATIENT HAD BEEN ABLE TO REMOVE IT BY HIMSELF. THE CATHETER WAS NOT REPAIRED BECAUSE THERE WAS NO REPAIR KIT AVAILABLE, THEREFORE, THE CATHETER WAS EXPLANTED/REMOVED AND REPLACED WITH OTHER COMPETITOR'S PRODUCT TO RESOLVE THE ISSUE. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS GIVEN VANCOMYCIN 1GRAM INTRAVENOUSLY AS INTERVENTION AND A NEW TUNNELED CENTRAL VENOUS CATHETER (TCVC) WAS REQUIRED TO BE PLACED WI TH ASSOCIATE

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

  MAUDE report 15754319 ↗
• DeathDec 21, 2018Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, ON INSERTION, THE INTRODUCER SHEATH/VALVED PULL-APART SHEATH AND PART OF THE SHEATH SHAFT HAS BROKEN OFF OR DETACHED FROM THE UPPER PART OF THE INTRODUCER SHEATH AND GOT STUCK DEEP INTO THE VENA JUGULARIS INTERNA SINISTRA (CATHETER WAS NOT INSIDE OF PULL-APART SHEAT). IT FOLLOWED EMERGENCY OPERATION UNDER XRAY, THE SHAFT OF THE INTRODUCER SHEATH/VALVED PULL-APART SHEATH WAS EXTRACTED. A NEW ONE WAS IMPLANTED DIRECTLY. IT WAS NOTED THAT THERE WAS NOTING UNUSUAL OBSERVED PRIOR TO USE, THERE WAS NO RESISTANCE FACED WHILE INSERTING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT PATIENT HAD BLOOD LOSS AND REQUIRED TWO 250ML BAGS OF BLOOD TRANSFUSED. PATIENT LATER DIED BUT AS PER THE PHYSICIAN, OTHER THINGS MAY BE RESPONSIBLE FOR PATIENT DEATH AS THE PATIENT IS MULTIMORBID.

  Patient problems: Blood Loss; Death; Radiation Exposure, Unintended

  MAUDE report 8191986 ↗

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-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-1886-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision HSI 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-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-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-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
• 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-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

…and 33 more.