Palindrome 8888541019PRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521158498), received between Oct 19, 2017 and Jul 28, 2021 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 reports).

49 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2021Misconnection; Material Integrity Problem; Misconnection; Material Integrity Problem

  ACCORDING TO THE REPORTER, AFTER THREE MONTHS OF INSERTION, DURING DIALYSIS, 15 MINUTES AFTER THE PATIENT'S CVC (CENTRAL VENOUS CATHETER) CONNECTED TO THE MACHINE LINES FOLLOWING THE DUE PROCEDURES DESCRIBED IN THE PROTOCOL OF DIALYSIS CVC MANAGEMENT, THE PATIENT'S CATHETER WAS DISCONNECTED FROM THE MACHINE BLOODLINE (SAME BRAND) CAUSING A BLOOD LEAK. THERE WAS A LEAK FROM THE BLUE (VENOUS) LUER ADAPTER BUT NO CRACK OBSERVED. 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. 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 ATTACK DID NOT MAKE A FULL TURN PRIOR TO USE. FLUSHING WAS DONE AND TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243252 ↗
• MalfunctionJul 28, 2021Misconnection; Material Integrity Problem; Misconnection; Material Integrity Problem

  ACCORDING TO THE REPORTER, AFTER THREE MONTHS OF INSERTION, DURING DIALYSIS,15 MINUTES AFTER THE PATIENT'S CVC (CENTRAL VENOUS CATHETER) CONNECTED TO THE MACHINE LINES 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. THERE WAS A LEAK FROM BLUE (VENOUS) LUER ADAPTER BUT NO CRACK OBSERVED. 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. 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 ATTACK DID NOT MAKE A FULL TURN PRIOR TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240817 ↗
• InjuryJul 28, 2021Misconnection; Material Integrity Problem; Misconnection; Material Integrity Problem

  ACCORDING TO THE REPORTER, 15 MINUTES INTO THE DIALYSIS SESSION, AFTER THE PATIENT'S CVC (CENTRAL VENOUS CATHETER) WAS CONNECTED TO THE MACHINE'S LINES AND THE PROCEDURE THAT WAS DESCRIBED IN THE PROTOCOL OF CVC DIALYSIS MANAGEMENT WAS BEING FOLLOWED, THE PATIENT'S CATHETER (VENOUS SITE) WAS DISCONNECTED FROM THE MACHINE LINE CAUSING A 300 ML (MILLILITER) OF BLOOD LOSS. IT WAS ALSO STATED THAT BLOOD TRANSFUSION WAS PERFORMED, THE TREATMENT WAS CONTINUED AND WAS COMPLETED. THE PATIENT CONTINUES TO USE THE CATHETER WHICH WAS NOT VISUALLY BROKEN. THE STAFF CHECKS THE CATHETER AND THE DORMOUSE WAS TIGHTENED SEVERAL TIMES DURING DIALYSIS TO RESOLVE THE ISSUE OF THE DEVICE. IT WAS OBSERVED ON THE DEVICE THAT THE FIXING RING DID NOT MAKE A FULL TURN, FLUSHING WAS PERFORMED WITH NORMAL RESULT, THE PLUGS OF HEMODIALYSIS OR LOCKING CAPS WERE PROVIDED OR UTILIZED AT THE DETACHMENT, THE NURSING STAFF HAVE INCREASE THE SUPERVISION AS THE INTERVENTION DONE, THE ADAPTERS WERE TIGHTEN BY HANDS AND NO OINTMENT WAS USED. THERE WAS A SLIGHT DRIPPING ON THE STERILE GAUZE THAT WAS WRAPS AROUND THE ENDS OF THE CVC. THE CATHETER WAS NOT REPAIRED, THERE WAS A LEAK AT THE LUER ADAPTER AND THE LUER ADAPTER

  Patient problems: Anemia

  MAUDE report 12239010 ↗
• MalfunctionJun 30, 2021Misconnection; Material Integrity Problem; Misconnection; Material Integrity Problem

  ACCORDING TO THE REPORTER, PRIOR TO TREATMENT, WHEN CONNECTING THE BLOODLINE, IT WAS OBSERVED THAT THE RING MADE A HALF TURN ONLY. AND THEN, DURING DIALYSIS TREATMENT, ABOUT 15 MINUTES AFTER PATIENT CONNECTION WITH CVC (CENTRAL VENOUS CATHETER) TO THE LINES OF THE MACHINE, THE CVC WAS DISCONNECTED (FROM THE MACHINE LINE) CAUSING A BLOOD LOSS. THE DISCONNECTIONS OF THE VENOUS LINE WAS SAID TO BE CAUSED BY THE DEFECTIVENESS OF THE MALE OR FEMALE LUER CONNECTION. IT WAS NOTED THAT THERE WAS A LEAKAGE AT THE LUER ADAPTER BUT THERE WAS NO CRACK. IT WAS REPORTED THAT THEY FOLLOWED THE APPROPRIATE PROCEDURES REPORTED IN THE PROTOCOL FOR THE MANAGEMENT OF CVC FROM DIALYSIS. THE CATHETER WAS NOT REPAIRED. AMUCHINAMED 0.05% WAS THE CLEANING AGENT USED ON THE DEVICE AND TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS LEFT FOR ABOUT 4-5 MINUTES ON THE CATHETER TERMINAL AND WERE REPLACED WITH DRY GAUZE AFTER THE CONNECTION. THE INSERTION SITE WAS TREATED WITH AMUCHINAMED 0.05% PRIOR TO PRODUCT PLACEMENT. HANDS WERE UTILIZED TO TIGHTEN THE ADAPTERS. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS AN UNKNOWN AMOUNT OF BLOOD LOSS BUT NO BLOOD TRANSFUSION WAS REQUIRED. NO MEDICAL INTERVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093221 ↗
• InjurySep 15, 2020Break; Break

  ACCORDING TO THE REPORTER, ON AUGUST 27TH WHILE AT HOME, THE PATIENT WHO WAS TO KNOWN TO HAVE DEMENTIA TRIED TO RIP THE CATHETER FROM HER NECK. THE PATIENT WAS ABLE TO SOMEHOW DETACH THE BACK END OF THE CATHETER AND AT THAT POINT REPORTEDLY LOST TWO PINTS OF BLOOD. THE PATIENT¿S HUSBAND SAW THIS OCCURRENCE AND APPLIED PRESSURE TO THE LUMENS STOPPING THE BLEEDING AND CALLED PARAMEDICS. THE PARAMEDICS TOOK THE PATIENT TO THE EMERGENCY ROOM AT THE LOCAL HOSPITAL AND TOOK AN X-RAY OF THE PATIENT. THEY LOOKED AT THE PATIENT¿S MEDICAL RECORDS AND SAW THAT THE CATHETER HAD BEEN PLACED ON JULY 29TH AND CALLED THE DOCTOR. THE DOCTOR ADVISED THEM TO NOT REMOVE OR FLUSH ANY PART OF THE CATHETER AND HAD THE PATIENT TRANSFERRED TO THE VASCULAR ACCESS FACILITY WHERE THE INTERNAL PORTION OF THE CATHETER STILL IN THE PATIENT WAS REMOVED AND REPLACED IT WITH AN ANTEGRADE DIALYSIS CATHETER. THE CATHETER WAS NOT REPAIRED, NO CATHETER LEAK AND NO LUER ADAPTER ISSUE. IT WAS STATED THAT NO BLOOD TRANSFUSION WAS REQUIRED.

  Patient problems: Blood Loss; Unintended Radiation Exposure

  MAUDE report 10537643 ↗
• MalfunctionJul 30, 2020Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN TUNNELING THE CATHETER, IT CAME APART. IT WAS STATED THAT THE HUB AND CATHETER SHAFT CAME APART AT THE CONNECTION SITE. IT WAS REPORTED THAT THE LUMENS WAS FLUSHED PRIOR TO USE. IT WAS STATED THAT THE PATIENT WAS ON LOCAL AND CONSCIOUS SEDATION (INSERTION). THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, NO OTHER PRODUCT WAS BEING UTILIZED WITH THE DEVICE. THEY HAD TO USE A DIFFERENT DEVICE AND HAD NO ISSUE AND WAS RESOLVED. NO INTERVENTION OR TREATMENT WAS REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10343092 ↗
• InjuryJun 20, 2018Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE CATHETER'S VENOUS LUER ADAPTER WAS DETACHED OR DISCONNECTED FROM THE FEATURE MANIPULATION ENGINE(FME) GENERATOR. THE PATIENT LOST 250ML OF BLOOD AND 2 POINTS OF HEMOGLOBIN BASED ON THE BLOOD NUMBERING REQUIRED BY THE PHYSICIAN. THE PATIENT WAS PLUGGED AGAIN AND FINISHED THE DIALYSIS SESSION. IT WAS STATED THAT WHEN THE CATHETER WAS USED ON FME GENERATORS, THE LUER LOCK COULD NOT BE SCREWED COMPLETELY AND THERE WAS AT LEAST ONE TURN OF THE SCREW MISSING WHICH INCREASES THE DISCONNECTION RISK.

  Patient problems: Blood Loss

  MAUDE report 7621385 ↗
• MalfunctionOct 19, 2017Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6) DURING INSERTION, THE DEVICE¿S GUIDE WIRE WAS BROKEN AT THE TIP MAKING IT UNABLE TO INSERT THE DILATATOR ON IT. AS A RESULT, THE PROCEDURE WAS EXTENDED. PATIENT OUTCOME IS UNKNOWN AT THIS TIME.

  Patient problems: No Information

  MAUDE report 6961001 ↗

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-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-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-1888-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision H 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-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-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-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-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-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

…and 34 more.