Palindrome 8888123410PRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521157811), received between Mar 19, 2018 and Aug 8, 2024 — classified as 2 injuries, 7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2024Disconnection; Material Puncture/Hole; Disconnection; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE PATIENT WITH KIDNEY FAILURE ARRIVED FOR HEMODIALYSIS AND HAD PRESSURE ALARMS. DURING DIALYSIS, THE STAFF, THROUGH FURTHER ASSESSMENT, BECAME AWARE OF A TEAR AND LEAK IN THE HEMODIALYSIS CVC (CENTRAL VENOUS CATHETER) ARTERIAL LUMEN JUST BELOW THE Y CONNECTOR (BIFURCATION), WHERE THE LUMEN ATTACHED THE THICKER TUBING, RESULTING IN AIR ENTERING THE DIALYSIS SYSTEM. THE CATHETER SHAFT HAD DISCONNECTED AT THE BIFURCATE/HUB. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE CLAMPS WERE MOVED PERIODICALLY, AS THIS WAS BEST PRACTICE. AS PER POLICY, THE LOCKING SOLUTION WAS REMOVED PRIOR TO USE, AND STAFF REPORTED NO ISSUES. THE LINE WAS USED ONLY TWICE A WEEK FOR 6 MONTHS. THEY FLUSHED IT TWICE WITH 10 ML (MILLILITERS) OF SALINE SYRINGES. CHLORAHEXIDINE GLUCONATE 2% W ISOPROPYL 70% WAS THE CLEANING AGENT USED ON THE DEVICE. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY. NO OINTMENT WAS USED. A TEGO CONNECTOR FOR CAPPING AFTER HEMO WAS UTILIZED. THE PATIENT DID NOT HAVE AN EXTERNAL SECUREMENT DEVICE USED (FOR EXAM PLE, A STAT LOCK, SIMPLE SUTURES TO THE WINGS, AND AN INITIAL INSERTION SITE REMOVED PER POLICY 8 WEEKS POST-INSERTION). THE PATIENT HAD TO UNDE

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

  MAUDE report 19942044 ↗
• MalfunctionAug 8, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHEN ATTEMPTING TO FLUSH THE VENOUS LUMEN, THE INTEGRITY OF THE CENTRAL LINE WAS COMPROMISED. A TEAR ON THE PATIENT'S LINES WAS PRESENT THAT LEAKED. HEMODIALYSIS DOUBLE LUMEN CENTRAL CATHETER NOTED SALINE LEAK FROM VENOUS (BLUE) LUMEN FROM THE AREA WHERE THE TWO CLEAR PLASTICS MEET BEFORE THE WHITE HUB DURING CONNECTION FOR HEMODIALYSIS. THEY CLAMPED AND SECURED IT UNTIL THEY WERE ABLE TO GET TO THE OR (OPERATING ROOM) TO HAVE IT REPLACED. AT-RISK, THE PATIENT MISSED A RUN AND HAD TO GET ANOTHER CENTRAL LINE PLACED. IT CAUSED INCONVENIENCE TO PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940158 ↗
• MalfunctionApr 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ROUTINE LINE CARE PRIOR TO CONNECTING TO THE HD (HEMODIALYSIS) MACHINE, WHILE THE HOME PATIENT WAS FLUSHING, THE CENTRAL VENOUS CATHETER RUPTURED. IT WAS ALSO STATED THAT IT MIGHT HAVE HAD A CLAMP ON BUT WAS AT HOME AND COULD NOT BE CONFIRMED. THE BALLOONING LUMEN WAS TORN OFF, AND THE TEGO CAP AND LUMEN END FLEW ACROSS THE ROOM. THE ADDITIONAL IMPACT WAS THAT THEY WERE UNABLE TO USE THE INSERTED DAMAGED DEVICE FOR DIALYSIS; THEREFORE, THE PATIENT MISSED DIALYSIS, INCREASING THE RISK OF AIR EMBOLISM, INFECTION, AND BLOOD LOSS. THE CATHETER WAS REMOVED AND REPLACED IN INTERVENTIONAL RADIOLOGY. THERE WAS NO INVASIVE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127166 ↗
• InjuryJun 16, 2023Product Quality Problem; Defective Component; Product Quality Problem; Defective Component

  ACCORDING TO THE REPORTER, DURING TEGO CHANGE BEFORE DIALYSIS TREATMENT, IT WAS NOTICED BY BEDSIDE NURSE THAT BOTH LUMENS (RED AND BLUE) WERE MOVING (JUST LOOSEN) AND NOT FIXED AT THE BIFURCATION HUB. LUER ADAPTERS WERE NOT THE ISSUE BUT THE HUB WAS THE ISSUE. THE LUMEN HUB (BIFURCATION) DID NOT DETACH FROM THE EXTENSION TUBE. THERE WAS NO LEAK. NO CLEANING AGENT USED ON THE DEVICE. NO EXCESSIVE FORCE APPLIED ON THE DEVICE. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT HAD NO ISSUE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. TEGO CONNECTOR WAS THE OTHER PRODUCT UTILIZED WITH THE DEVICE. NEPHROLOGIST INFORMED AND AN ORDER RECEIVED TO HAVE THE CVC (CENTRAL VENOUS CATHETER) EXCHANGED. PATIENT NEEDS TO HAVE CVC TO BE CHANGE IN ORDER TO BE DIALYZED HENCE DELAY IN TREATMENT OR CARE (UNEXPECTED OR PROLONGED CARE). NO INVASIVE PROCEDURE AS THE PROCEDURE WAS JUST A CVC EXCHANGE OR INSERTION OF NEW CVC WHICH WAS PROCEEDED ON (B)(6), 2023 AND THE PROCEDURE WAS COMPLETED. THE EVENT DID NOT LEADTO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 17145966 ↗
• MalfunctionAug 19, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE 23CM CVC (CENTRAL VENOUS CATHETER) WAS UNABLE TO ASPIRATE FROM EITHER LUMEN OF THE CATHETER FOR HEMODIALYSIS AND NEEDED TO BE REPLACED. TPA (TISSUE PLASMINOGEN ACTIVATOR) WAS USED FOR 30 MINUTES FOR SHORT DWELL, FOLLOWED BY A "LONG DWELL" OVERNIGHT AND THE CATHETER WAS STILL NOT FUNCTIONING. THE CVC WAS IDENTIFIED AS PART OF THE RECALL AND THE PATIENT HAD BEEN INFORMED ON JUNE 23, 2022 THAT IF TPA "LONG DWELL" DID NOT WORK, THE PATIENT MAY NEED AN EXCHANGE OF THE CATHETER. THE CVC WAS REMOVED AND REPLACED ON (B)(6) 2022, AND HAD HD TREATMENT. THE PATIENT WAS BROUGHT DOWN TO THE DIAGNOSTIC IMAGING FROM RAH IN-CENTRE HEMODIALYSIS UNIT. IT WAS ALSO STATED THAT THE PATIENT'S CVC WAS REPLACED WITH A FUNCTIONING ONE WHICH WAS NOT PART OF THE RECALL LIST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259744 ↗
• MalfunctionAug 2, 2022Insufficient Flow or Under Infusion; Defective Component; Insufficient Flow or Under Infusion; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT'S CATHETER WAS AMONG THE DEFECTED/RECALLED CATHETER. IT WAS NOTED THAT THE CATHETER WAS POORLY FUNCTIONING (POOR PUMP SPEED AND CONSTANT PRESSURE ALARMS). THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. IT WAS SAID THAT AN ORDER WAS ENTERED FOR CENTRAL VENOUS CATHETER (CVC) REMOVAL AND REPLACEMENT. PATIENT WAS SENT FOR CVC LINE EXCHANGE INVASIVE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15146178 ↗
• MalfunctionApr 2, 2021Material Puncture/Hole; Detachment of Device or Device Component; Material Puncture/Hole; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE CVC (CENTRAL VENOUS CATHETER) LINE WAS RUPTURED WHILE BEING FLUSHED (LINE WAS NOT RUNNING WELL). IT RUPTURED IN THE CLEAR LUMEN TUBING AND THE RED SIDE OF THE CATHETER LINE WAS SEPARATED (IT WAS NOT CROSS THREADED). THE EXTENSION DID NOT DISCONNECT, AND THE LINE WAS RUPTURED. PHYSICIAN WAS NOTIFIED AND THE LINE EXCHANGE/REPLACEMENT WAS ORDERED. PRIOR TO REPLACEMENT AND IN ORDER TO PREVENT BLOOD LOSS (THERE WAS A SMALL AMOUNT OF BLOOD LOSS), THE CATHETER WAS CLAMPED. THE CATHETER WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. THE TREATMENT WAS THEN COMPLETED AFTER THE REPLACEMENT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. 2% CHLORHEXIDINE GLUCONATE (CHG) AND 70% ISOPROPYL ALCOHOL WERE THE CLEANING AGENTS USED ON THE DEVICE. TEGO WAS UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO LUER ADAPTER ISSUE. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607738 ↗
• MalfunctionMar 19, 2018Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT HAD A PINPOINT HOLE IN HIS CATHETER. NO REPORTED PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7348891 ↗
• MalfunctionMar 19, 2018Break; Break

  CUSTOMER REPORTS THAT THE PATIENT'S CATHETER HAD A HOLE IN IT. THE CATHETER WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7348818 ↗

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-1888-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision H 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-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
• Z-0332-2016 · 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: 8888145046C The Palindrome chronic catheter is intended for

…and 32 more.