Palindrome 8888145048CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521158146), received between Apr 30, 2019 and Aug 29, 2022 — classified as 1 death, 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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-1315-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• DeathAug 29, 2022Defective Component; Adverse Event Without Identified Device or Use Problem; Defective Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS ADMITTED AND A PERM HEMODIALYSIS (HD) CATHETER WAS INSERTED. ON (B)(6) 2022, IT WAS SAID THAT THERE WAS A SEAL ALERT RECEIVED REGARDING RECALL OF AFFECTED CATHETERS FROM OUR COMPANY. THE ALERT STATED THAT OUR COMPANY HAS IDENTIFIED POTENTIAL LEAKING AT THE HUB AND RECALLED THE AFFECTED DEVICES. THE CATHETER WAS ALREADY INSERTED TO THE PATIENT (INTERNAL JUGULAR VESSEL, TERMINATED OUT THE CHEST) BEFORE THE ALERT WAS RECEIVED ON JULY 8. FLUSHING PERFORMED PRIOR TO INSERTION AND NO ABNORMALITIES NOTED OR REPORTED. DURING RETROSPECTIVE SURVEILLANCE, THE PATIENT WAS IDENTIFIED TO A HAVE A CENTRAL LINE ASSOCIATED BLOODSTREAM INFECTION (CLABSI) (CATHETER ASSOCIATED INFECTION). THE TYPE OF INFECTION THAT THE PATIENT HAD WAS PNEUMONIA; BACTEREMIA. WITH EVENT DATE OF (B)(6) 2022. THERE WERE A POSITIVE 2/4 BOTTLES ENTEROCOCCUS FAECIUM. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. ALCOHOL PAD WAS THE CLEANING AGENT USED ON THE DEVICE. CLEAN GUARDS AND TEGOS WERE UTILIZED WITH THE DEVICE. THE INSERTION SITE WAS TREATED WITH CHLORAPREP (DURAPREP IF IODINE ALLERGY) PRIOR TO PRODUCT PLACEMENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Fever; Pneumonia; Septic Shock

  MAUDE report 15312585 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE PATIENT HAD INFECTION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Unspecified Infection

  MAUDE report 15269600 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE PATIENT HAD INFECTION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Unspecified Infection

  MAUDE report 15262677 ↗
• MalfunctionJul 28, 2021Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  ACCORDING TO THE REPORTER, ON THE DAY OF CATHETER INSERTION, DURING DIALYSIS, 15 MINUTES AFTER THE PATIENT'S CVC (CENTRAL VENOUS CATHETER) CONNECTED TO THE MACHINE WITH COMPETITOR'S BLOODLINE FOLLOWING THE DUE PROCEDURES DESCRIBED IN THE PROTOCOL OF DIALYSIS CVC MANAGEMENT, THE PATIENT'S CATHETER WAS NOT DISCONNECTED BUT IT WAS LOOSENED JUST ENOUGH FROM THE MACHINE LINE TO ALLOW FOR A SMALL AMOUNT OF BLOOD. THE DEVICE WAS NOT BROKEN, BUT THE NURSE STATED THAT IT DID NOT HAVE A SECURE TIGHTENING. THERE WAS NO BLOOD LOSS, IF NOT IN AN INSIGNIFICANT AMOUNT, IT ONLY CONTAMINATED THE CONNECTION. THERE WAS LEAK FROM BLUE (VENOUS) LUER ADAPTER BUT NO CRACK OBSERVED. THE NURSE NOTED THAT IN PERFORMING THE LINE CONNECTION MANEUVER TO THE CVC, THE THREAD OF BOTH LUMENS (VENOUS AND ARTERIAL) REMAINS STAINED WITH BLOOD, WITH SLIGHT DRIPPING ON THE GAUZE STERILE THAT WRAPS AROUND THE ENDS OF THE CVC. THEY LEAVE THE CONNECTIONS ON SIGHT SO THAT IF THERE SHOULD BE A BLOOD LOSS OR DISCONNECTION, THERE WERE READY TO INTERVENE. THE TREATMENT WAS PROCEEDED AND COMPLETED. THE CAPS OF THE ATTACHMENT AND DETACHMENT KIT (COMBI STOPPER) WAS UTILIZED. IT WAS ALSO MENTIONED THAT THE LUER CONNEC TION DID NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243552 ↗
• InjuryNov 3, 2019Product Quality Problem; Material Deformation; Product Quality Problem; Material Deformation

  ACCORDING TO THE REPORTER, THE PATIENT WAS HOSPITALIZED DUE TO TUNNEL INFECTION WHICH WAS TREATED WITH INTRAVENOUS (IV) VANCOMYCIN. IT WAS STATED THAT AIR BUBBLES WERE STILL NOTED ON THE SILVER COATING OF THE DEVICE. IT WAS ALSO NOTED THAT THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. A NEW CATHETER WAS INSERTED TO THE PATIENT WITHOUT SILVER COATING, AND THE PATIENT WAS EVENTUALLY DISCHARGED AND STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 9270660 ↗
• InjuryMay 1, 2019Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE IMPLANTED DEVICE WAS OBSERVED TO CONTAIN WOUND SECRETIONS, WHEREIN THE PATIENT¿S AUSTRITT (EXIT SITE) SITE (WHERE THE CATHETER¿S SILVER COATING WAS LOCATED) HAD SECRETIONS WHICH WAS SMEARED AND REVEALED THE FOLLOWING BACTERIAL SPECIES; COAGULASE (B)(6) AND CORYNE BACTERIUM SPECIES. MEDICAL INTERVENTION TO TREAT THE INFECTION INCLUDED; OCTENISEPT WITH ALCOHOL (FOR CLEANING), FUCIDINE (FOR TREATMENT OF INFECTION), AND MEDICAL HONEY (FOR TREATMENT OF INFECTION) TO RESOLVE THE ISSUE. THE CATHETER WAS STILL IN PATIENT AND WORKS WELL.

  Patient problems: Unspecified Infection

  MAUDE report 8568559 ↗
• MalfunctionApr 30, 2019Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, AIR BUBBLES WAS FORMED ON THE SILVER COATING AND WERE STILL THERE. CATHETER WAS STILL IN PATIENT AND WORKS WELL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8567467 ↗

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-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-1886-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision HSI 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-1889-2025 · Apr 23, 2025 · Open, Classified
  MAHURKAR 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-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-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.