Palindrome 8888128454PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521157842), received between May 30, 2018 and Dec 13, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

47 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. Apr 23, 2025Class IIOpen, Classified

   Potential breach of sterile barrier packaging.

   Z-1885-2025 · Root cause: Packaging · Recall details · FDA record ↗

2. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, AT HOME, WHEN THE PATIENT CHANGED HIS TEGO CAP, THE PATIENT NOTED A BLOOD LEAKAGE FROM THE ARTERIAL PORT OF THE CATHETER BUT WHILE DURING INSPECTION, THE CRACK WAS FOUND IN THE CVC (CENTRAL VENOUS CATHETER) LUMEN WHERE THE COLORED CONNECTOR ATTACHED TO THE CVC LINE. THE PATIENT CALLED THE HOME HEMODIALYSIS NURSE AND WAS INSTRUCTED TO CLAMP IT AND NOT USE IT AND TO COME INTO THE HEMODIALYSIS UNIT FOR DIALYSIS. IT WAS SAID THAT THE PATIENT HAD TO RUN IN-CENTER AND THEY HAD TO NEEDLE THE PATIENT'S NEW AVF (ARTERIOVENOUS FISTULA) FOR THE ARTERIAL SUPPLY. THERE WAS NO INVASIVE PROCEDURE DONE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984425 ↗
• MalfunctionApr 21, 2021Defective Component; Infusion or Flow Problem; Defective Component; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CVC (CENTRAL VENOUS CATHETER) LUMENS WERE BULGING BILATERALLY (NOT PERFORMING WELL) WHEN FLUSHING. THE CVC LINE WAS STILL ABLE TO FLUSH, BUT THERE WAS AN INSUFFICIENT OR MINIMAL FLOW. IT WAS STATED THAT THE CUSTOMER TRIED TO REVERSE THE LINES AS AN INTERVENTION. THE SYSTEM WAS RECIRCULATED PRIOR TO SYRINGE FLUSH. THE CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO EXCESSIVE FORCE APPLIED WHEN FLUSHING WAS DONE AND NO BLOCKAGE THAT CAN CAUSE THE LINE TO BULGE. CHLORHEXIDINE CHG WAS THE CLEANING AGENT USED ON THE DEVICE. POVIDONE IODINE WAS THE CLEANING AGENT USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT REPAIRED. TEGO WAS UTILIZED. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT OBSERVED. THERE WAS NO PACKAGING DAMAGE OR DAMAGE IN THE INNER PACKAGING. THE STERILE BARRIER WAS STILL INTACT UPON RECEIPT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700113 ↗
• MalfunctionOct 20, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER HAD A PIN PRICK HOLE AND LEAK. THE CATHETER WAS NOT REPAIRED AND 2% CHLORHEXIDINE WITHOUT ALCOHOL WAS USED AS THE CLEANING AGENT ON THE DEVICE. TEGO WAS NOT UTILIZED. THE PATIENT HAD BLEEDING (SMALL AMOUNT). THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10706029 ↗
• MalfunctionJul 3, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THERE WAS A BARELY VISIBLE (TINY) PUNCTURE HOLE FOUND ON THE UNDERSIDE OF THE SOFT LUMEN OF THE CATHETER DURING DIALYSIS TREATMENT. IT WAS ALSO STATED THAT THE NURSE SAW ONLY SMALL DROPS OF BLOOD ON THE PATIENT'S CLOTHING. THE TREATMENT WAS STOPPED AND A SINGLE-LUMEN DIALYSIS TREATMENT WAS COMPLETED. CLAMPS WERE MOVED ABOVE THE PUNCTURED HOLES UNTIL REINSERTION OF THE GUIDE WIRE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8759055 ↗
• MalfunctionMay 30, 2018Hole In Material; Hole In Material

  ACCORDING TO THE REPORTER, THE PATIENT HAD A DIALYSIS TREATMENT VIA THE CATHETER, AND THE NURSE NOTED THAT THERE WAS ONLY ONE HUB SUTURE IN-SITU, SO AN IMMOBILIZER DEVICE WAS APPLIED. IT WAS UNCERTAIN IF THERE WAS AN IMMOBILIZER USED ON THE PATIENT PRIOR TO THIS. THE PATIENT WAS PRESENTED TO THE RENAL UNIT WITH FRESH BLOOD UNDER THE CATHETER DRESSING. THE NURSE WHO ATTENDED THE PATIENT DOCUMENTED THAT THE PATIENT SAID THEY WERE CARRYING A BAG OF HEAVY GROCERIES AGAINST THEIR CHEST, AT SOME POINT FELT SOME DEGREE OF PAIN, BUT THOUGHT MAYBE THEY HAD JUST AGGRAVATED OR PULLED OUT THE REMAINING SUTURE. A NURSE REMOVED THE CATHETER DRESSING FOR ASSESSMENT OF THE BLEEDING, AND A HOLE OR SLIT WAS DISCOVERED ON THE ARTERIAL LUMEN OF THE CATHETER'S EXTENSION. THE NURSE DID NOTE THAT THERE WAS NO LONGER AN IMMOBILIZER/STABILIZER IN PLACE UNDER THE CATHETER, AND THE PATIENT DID ADMIT TO REMOVING THIS DEVICE THEMSELVES. THE PATIENT DENIES USING AN INSTRUMENT TO REMOVE THE IMMOBILIZER DEVICE. THERE WAS NO DOCUMENTATION INDICATING THE PATIENT REPORTED ON AN APPROXIMATE AMOUNT OF BLOOD LOST BETWEEN THE LUMEN BECOMING COMPROMISED, AND PRESENTATION TO THE RENAL UNIT WITH CONCERNS ABOUT BLOOD UNDER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7555289 ↗

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-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-1887-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision SI 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-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-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-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-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-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-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-0331-2016 · Oct 14, 2015 · Terminated
  Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for

…and 32 more.