Palindrome 8888145040Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521056664), received between Jul 9, 2018 and Jul 10, 2025 — classified as 1 death, 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K111372); 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-1316-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT HEMODIALYSIS TREATMENT IN THE HOSPITAL DUE TO KIDNEY FAILURE. DUE TO POOR VASCULAR CONDITIONS, A CHRONIC CATHETER SET WAS USED FOR DIALYSIS. DURING THE PROCEDURE ON THE SAME DAY, WHEN THE CATHETER WAS PLACED, A CRACK WAS OBSERVED AT THE VENOUS LUER ADAPTER OF THE CATHETER, RESULTING IN A BLOOD LEAK AT THE ADAPTER. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, AND NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THE CATHETER WAS REPAIRED ON THE SAME DAY BY IMMEDIATELY REPLACING THE ADAPTER TO CONTINUE THE PATIENT'S DIALYSIS AS THE INITIAL DISPOSITION AND THE DIALYSIS THERAPY WERE COMPLETED. THE AMOUNT OF BLOOD LOST AS A RESULT OF THE EVENT WAS UNSPECIFIED, AND NO BLOOD TRANSFUSION WAS REQUIRED. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THE PATIENT DID NOT HAVE CROSS-INFECTION DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472925 ↗
• InjurySep 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING DIALYSIS, A CATHETER CUFF WAS DISLOCATED. THE CATHETER HAD TO BE REMOVED DUE TO ELEVATED RISK OF TOTAL DISLOCATION/BLEEDING OR INFECTION. ON 11TH OF APRIL 2024, A NEW CATHETER WAS INSERTED. A MEDICAL INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20190253 ↗
• MalfunctionAug 27, 2024Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  ACCORDING TO THE REPORTER, DURING DIALYSIS, A CATHETER CUFF WAS DISLOCATED. THE CATHETER HAD TO BE REMOVED AS ACTION DUE TO THE ELEVATED RISK OF COMPLETE CATHETER DISLOCATION, BLEEDING, OR INFECTION AT THE TIME OF REMOVAL. ON (B)(6) 2024, A NEW CATHETER WAS INSERTED. NO MEDICAL INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. NO MEDICATIONS WERE GIVEN TO THE PATIENT DUE TO THE EVENT. NO BLOOD CULTURES WERE PERFORMED. THERE WAS NO BLEEDING OR INFECTION. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075955 ↗
• MalfunctionDec 22, 2023Break; Material Puncture/Hole; Break; Material Puncture/Hole

  ACCORDING TO THE REPORTER, UPON ARTERIAL ASPIRATION AFTER BEING IN DIALYSIS FOR SEVERAL MINUTES, A 30 CM (CENTIMETER) STRIP OF AIR WAS SEEN IN THE PIPING OF THE CIRCUIT. AFTER NOTICING IT, DIALYSIS WAS INTERRUPTED. NO AIR WENT TO THE PATIENT. THE PATIENT WAS DISCONNECTED. AFTER REMOVAL, THE CATHETER WAS SENT TO THE HOSPITAL TECH DEPARTMENT IN TWO PIECES. THESE WERE BOTH CLEARED OF BLOOD DEBRIS (BLOOD RESTS) VIA OXYGENATED WATER AND FLUSHED WITH WATER, AND AFTERWARDS THEY WERE DISINFECTED WITH CHLORHEXIDINE GLUCONAS 2% (70% ETHANOLUM) AS CLEANING AGENTS USED ON THE DEVICE. THE END OF THE CATHETER WAS CLAMPED OFF AND CONNECTED VIA THE VENOUS AND ARTERIAL LUMEN TO A SYRINGE FILLED WITH 0.9% NACL (SODIUM CHLORIDE). BOTH SYRINGED THROUGH, WITH NOTHING TO BE SEEN. AFTERWARDS, ASPIRATION WAS PERFORMED, AND NOTHING WAS SEEN THERE EITHER. THEY PERFORMED THE PROCEDURE AGAIN WITH THE CATHETER SUBMERGED IN WATER. THEREAFTER, BOTH LUMENS WERE PERFUSED WITH AIR, AND AIR BUBBLES WERE SEEN AT THE LEVEL OF THE ARTERIAL CONNECTOR. IT WAS APPROXIMATELY AT THE WIRE (THREAD) SECTION. IT WAS ALSO STATED THAT AIR HAD LEAKED THROUGH A TINY HOLE THAT WAS NOT VISIBLE TO THE EYE IN THE ARTERIAL LUMEN OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387241 ↗
• DeathMay 12, 2022Migration; Migration

  ACCORDING TO THE REPORTER, DURING NORMAL USE, IT WAS FOUND THAT THE CATHETER WAS OUT OF POSITION, THE CUFF COULD NOT SECURE THE POSITION AND THE WHOLE CATHETER WAS SLIPPING AWAY FROM THE BODY. THE CUFF COULD BE SEEN AT EXIT SITE. THE PATIENT DID NOT EXPERIENCE ANY HARMS FOR THAT. THE PATIENT REQUIRED DIAGNOSTIC TESTING AS A RESULT OF THIS EVENT. THEY REPLACED IT BY ANOTHER MANUFACTURER'S PRODUCT. THE CUSTOMER CLAIMED THAT THE PATIENT IS NOW USING ACUTE CATHETER AT FEMORAL VEIN INSTEAD OF REPLACEMENT OF LONG-TERM CATHETER. THE CATHETER HAD NO LEAK AND IT WAS NOT REPAIRED. MACHINE ALARMS NOTED DURING DIALYSIS. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. IT WAS STATED THAT THE IMPLANTATION OCCURRED AT (B)(6) 2022, X-RAY CHECK IN (B)(6) 2022, DETACHMENT FOUND, REPOSITION AFTER THAT, PATIENT CAME BACK HOSPITAL TO HAVE HEMODIALYSIS, AND FOUND OUT THIS PROBLEM DURING HEMODIALYSIS. THE CUSTOMER SAID THAT THE PATIENT HEALTH AND SITUATION BECAME WORSE THAN BEFORE AND AFTER THAT THE PATIENT KEPT STAY IN HOSPITAL. THE CUSTOMERS SAID THAT THE REASON OF PATIENT HOSPITALIZATION IS CURRENTLY UNKNOWN. THE TREATMENT IS NOT YET COMPLETED, THE PATIENT IS STILL IN HOSPITAL AS FURTHER TREATMENT

  Patient problems: Insufficient Information; Unintended Radiation Exposure

  MAUDE report 14376319 ↗
• MalfunctionMar 23, 2022Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT WAS BLEEDING IN THE AREA OF EXIT SITE. A CRACK WAS OBSERVED AT THE LUER ADAPTER. THE CATHETER WAS REPAIRED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 13862737 ↗
• InjuryMar 10, 2021Misconnection; Misconnection

  ACCORDING TO THE REPORTER, WHEN PATIENT HAD BEEN ON TREATMENT FOR 20 MINUTES, LEAK OCCURRED AS A RESULT OF THE DISCONNECTION OF THE VENOUS LUMEN OF THE CATHETER FROM THE BLOODLINES (DIFFERENT BRAND). THE BLOOD LINES HAD BEEN SCREWED INTO THE LUER ENDS OF THE CATHETER AND THE VENOUS ONE HAD SLIPPED OFF AND NOT BEEN PHYSICALLY UNSCREWED BUT ARTERIAL CONNECTION REMAINED SECURED. AFTER DISCONNECTION OCCURRED, LUER LOCK SYRINGES WERE ATTACHED TO BOTH ARTERIAL AND VENOUS LUMEN AND THE VENOUS THOUGH NOT EASILY NOTICED, APPEARED TO HAVE LESS THREAD. THE PATIENT HAD BEEN HAD BEEN ON A COMPETITOR'S MACHINE (SAME BRAND AS THE BLOODLINES). THERE WAS NO CONTINUITY OR ANY ISSUES WITH LOOSE LINES. ARTERIAL PRESSURES WERE ON AVERAGE BETWEEN -100 AND -140 AND VENOUS PRESSURES BETWEEN 80 AND 120, PUMP SPEED 250-270 (ALL WITHIN THE EXPECTED RANGE FOR DIALYSIS USING A CATHETER). THE CATHETER WAS NOT REPAIRED AND CHLORHEXIDINE 2% WAS USED AS THE CLEANING AGENT ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NOTHING UNUSUAL NOTED ON THE DEVICE PRIOR TO USE. IT WAS MENTIONED THAT THE PATIENT HAS KNOWN HYPERSENSITIVITIES TO DRESSINGS; TOLERATES A TEGADERM CHG. THE PATIENT HAD BEEN ADVISED SEVERAL TIMES NO

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypovolemia

  MAUDE report 11452706 ↗
• MalfunctionJan 28, 2020Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING THE DIALYSIS TREATMENT, THERE WAS A LEAK (A FEW TRAYS OF "SALINE 09%") ON THE BLUE OR VENOUS CONNECTOR (LUER ADAPTER). THERE WAS A HAIRLINE CRACK OBSERVED IN THE LUER ADAPTER AND OCTENISEPT ALCOHOL-FREE WAS USED AS A CLEANING AGENT ON THE DEVICE. TEGO FOR SINGLE-NEEDLE PROCEDURE WAS UTILIZED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE AND FLUSHING WAS DONE WITH SALINE/SODIUM CHLORIDE (NACL) 0.9% WHICH WAS USED TO BLOCK INSTEAD OF HEPARIN OR CITRATE BECAUSE THEY USED TEGO. IT WAS MENTIONED THAT THERE WAS NO BLOOD LEAK AND BLOOD TRANSFUSION WAS NOT REQUIRED. THEY SWITCHED TO THE SINGLE-LUMEN TREATMENT (ARTERIAL / RED EXTENSION), AND IN THE END, THE LEAK WAS REPAIRED WITH A REPAIR KIT. EVERYTHING WAS OKAY AFTER THE REPAIR AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9639255 ↗
• MalfunctionApr 9, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING HEMODIALYSIS (HD) SESSION, THERE WAS BLEEDING AT THE INSERTION SITE (EXIT SITE) WITHOUT SIGNS OF INFECTION AND THERE WAS VENOUS LUMEN MICRO FISSURE. A CHANGE OF HD CATHETER WAS REQUESTED TO RESOLVE THE ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. IT WAS ALSO STATED THAT THE CATHETER WAS NOT REPAIRED AND HAD NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8496654 ↗
• MalfunctionMar 27, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE PATIENT'S VITAL SIGNS WERE STABLE WITHIN NORMAL RANGE AND NO ABNORMALITIES WERE NOTED, HOWEVER, THE STAFF COULD ONLY ACHIEVE A BLOOD FLOW RATE OF 250 ML/MIN INSTEAD OF THE DESIRED 300 ML/MIN DUE TO A HIGH NEGATIVE ARTERIAL PRESSURE. DURING TREATMENT WHEN THE PATIENT WAS CONNECTED TO THE MACHINE, THERE WAS A LEAK AND A HOLE WAS FOUND IN THE VENOUS LUMEN WITHIN THE WHITE CLAMP SEGMENT OF THE CATHETER. IT WAS NOTED THAT A TEGO WAS NOT UTILIZED AND THE PATIENT HAS A HISTORY OF HYPERTENSION. THE ACCESS WAS CLAMPED OFF AFTER THE DIALYSIS WAS ABANDONED. THE EXIT SITE WAS LEFT WITH THE DRESSING INTACT AND THE CATHETER LUMENS WERE DISINFECTED WITH 2% CHLORHEXIDINE IN 70% ALCOHOL PER THE HOSPITAL POLICY. THE PATIENT WAS READMITTED IN THE HOSPITAL AND THE CATHETER WAS COMPLETELY EXPLANTED. PERITONEAL DIALYSIS WAS THE LONG TERM ACCESS FOR THE PATIENT'S DIALYSIS BUT AN ATTEMPT WAS MADE TO INSERT A NEW CATHETER VIA THE LEFT INTERNAL JUGULAR. THE ATTEMPT FAILED AS THEY WERE UNABLE TO PASS THROUGH THE CENTRAL VEINS AND SUPERIOR VENA CAVA, HENCE, A NEW TEMPORARY ACCESS WAS INSERTED IN THE FEMORAL VEIN.

  Patient problems: No Code Available; No Consequences Or Impact To Patient; No Information

  MAUDE report 8457284 ↗
• MalfunctionJul 17, 2018Break; Fluid/Blood Leak; Fracture; Material Puncture/Hole; Break; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THERE WAS A LEAK AT THE JUNCTION OF THE EXTENSION TUBE AND THE BIFURCATE. THE LINE WAS NOTED TO BE FRACTURED AND LEAKING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7696329 ↗
• MalfunctionJul 9, 2018Break

  ACCORDING TO THE REPORTER, A SMALL FRAGMENT OF PLASTIC BROKE OFF INSIDE THE BLUE LUMEN OF THE CATHETER IN A PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7670218 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111372. One submission often covers many models, so check the product and lot details in each record.

• Z-2632-2023 · Aug 22, 2023 · Open, Classified
  Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
• Z-1320-2022 · Jun 8, 2022 · Open, Classified
  Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.