Palindrome 8888145018Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521013216), received between Mar 11, 2019 and Mar 5, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (6 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.

• InjuryMar 5, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, DURING HEMODIALYSIS, IT WAS FOUND THAT THE CATHETER WAS NOT PROVIDING ADEQUATE BLOOD FLOW, WHICH RESULTED IN INEFFECTIVE DIALYSIS. THERE WAS NO LEAK. IT WAS MENTIONED THAT THE INSTRUCTION WAS FOLLOWED WHEN THE PRODUCT WAS USED. THE CATHETER WAS NOT REPAIRED. IT WAS STATED THAT THE CATHETER HAD TO BE REPLACED IN THE OPERATING ROOM AS A SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT. IT WAS STATED THAT THE EVENT LEAD TO EXTENDED HOSPITALIZATION.

  Patient problems: Insufficient Information

  MAUDE report 21525681 ↗
• MalfunctionFeb 4, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING NORMAL USE, THERE WAS A LEAK AT THE JUNCTION OF THE VENOUS EXTENSION TUBE AND BIFURCATE OF THE CATHETER. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS NOT DONE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE CLAMP WAS MOVED PERIODICALLY. AN UNSPECIFIED NAME OF A CLEANING AGENT WAS USED ON THE DEVICE. THE PRODUCT WAS REPLACED WITH THE SAME PRODUCT ID (IDENTIFIER) AND LOT AS THE INTERVENTION AND THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305901 ↗
• MalfunctionMar 17, 2023Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, DURING INSERTION, THE CATHETER HAD A LEAK. THE CATHETER WAS NOT REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564605 ↗
• InjuryOct 18, 2022Break; Break

  ACCORDING TO THE REPORTER, IMPLANTATION OF THE CATHETER WAS PERFORMED IN THE PATIENT ON (B)(6) 2022, WITHOUT INTERCURRENCES/WITHOUT COMPLICATIONS, WITH CONTROL PHLEBOGRAPHY WITHOUT RADIOANATOMICAL COMPLICATIONS. THE PATIENT WAS UNDERGOING HEMODIALYSIS SATISFACTORILY, HOWEVER, FOR ABOUT 2 WEEKS THE PATIENT PRESENTED WITH REPEATED EPISODES OF HEMOPTYSIS. IMAGING INVESTIGATION SHOWED A CATHETER TIP FRAGMENT IMPACTED IN THE LOWER BRANCH OF THE RIGHT PULMONARY ARTERY, WITH AN AREA OF HEMATOMA AROUND THE CATHETER FRAGMENT. THE REMAINDER OF THE CATHETER WAS ARRANGED ALONG THE VENA CAVA AND REMAINED FUNCTIONAL. THE CATHETER WAS NOT REPAIRED, THERE WAS A LEAK AT THE CATHETER TIP FRAGMENT IN PULMONARY ARTERY D AND THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER WAS PART OF THE PRODUCT BEING RECALLED. THE REPORTED CATHETER WAS EXPLANTED.

  Patient problems: Foreign Body In Patient; Hematoma; Hemoptysis; Unintended Radiation Exposure

  MAUDE report 15621451 ↗
• InjuryFeb 22, 2022Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, FLUSHING WAS DONE SUCCESSFULLY. DURING INSERTION AT THE RIGHT FEMORAL VEIN, CATHETER TIP WAS NOT PASSING THROUGH THE TIP OF THE PULL APART SHEATH, BEFORE THE CATHETER WAS INSERTED, AFTER REPEATED ATTEMPTS, THE PULL APART SHEATH BENT, SPLIT MIDWAY (AT THE MIDDLE), STAYED IN THE PATIENT BODY FOR A FEW MINUTES. NO ADDITIONAL SURGICAL PROCEDURE REQUIRED. BOTH PARTS WERE RETRIEVABLE, RETRIEVED MANUALLY WITH HELP OF FORCEPS ON THE SAME DAY OF THE EVENT, X-RAY MACHINE PERFORMED TO MAKE SURE ALL THE PIECES WERE RETRIEVED, AND ALL PIECES WERE ACCOUNTED FOR. FOLLOWING THE PULL APART SHEATH FAULT, THE CATHETER WAS REMOVED AND NEW CATHETER WITH SIMILAR MODEL NUMBER AND SAME LOT WAS USED ON THE SAME DAY OF THE EVENT, THE PULL APART SHEATH WAS DISCARDED, A NEW SHEATH CAME FROM THE REPLACEMENT KIT UTILIZED, THE NEW CATHETER WAS SUCCESSFULLY INSERTED ON THE SAME INSERTION SITE, SUBSEQUENTLY GOOD BACK FLOW WAS ALSO OBSERVED AND THE PROCEDURE WAS COMPLETED. NO RESISTANCE ENCOUNTERED AND NO EXCESSIVE FORCE USED WHEN INSERTING THE CATHETER TIP TO THE PULL APART SHEATH. THERE WAS NO LEAK FROM VALVE OF THE SHEATH, THERE WAS NO ATTEMPT TO SPLIT THE PULL APAR

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 13580842 ↗
• MalfunctionOct 8, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, DURING FLOW AND REFLUX TEST, A LEAK WAS SEEN NEAR THE BLUE HUB OF THE CATHETER, REQUIRING REPLACEMENT. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12597081 ↗
• MalfunctionSep 16, 2021Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, WHEN THE PATIENT CAME FOR THE DIALYSIS TREATMENT AFTER 2 DAYS FROM THE INSERTION, IT WAS FOUND THAT THERE WAS A CRACK AT THE BLUE (VENOUS) LUER ADAPTER AND LEAK WAS SEEN BY THE HCP (HEALTH CARE PROFESSIONAL) DURING THE HEMODIALYSIS TREATMENT. THE TREATMENT WAS PROCEEDED AND COMPLETED AFTER REMOVING THE CATHETER AND INSERTING A NEW ONE USING THE OTHER COMPANY'S PRODUCT, AND IT WAS THE INTERVENTION/TREATMENT REQUIRED FOR THE LEAKAGE. THERE WAS AN UNSPECIFIED BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS PERFORMED AND NOTHING ABNORMAL WAS FOUND. THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT, THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT, CHLOROHEXIDINE GLUCONATE SOLUTIONS WAS USED AS THE CLEANING AGENT TO CLEAN THE ADAPTERS AND THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING THE OINTMENT TO THE AREA. THE CATHETER WAS NOT REPAIRED, THERE WAS NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE, CHLOROHEXIDINE GLUCONATE SOLUTIONS WAS USED AS THE CLEANING AGENT ON THE DEVICE, TEGO WAS NOT U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12480677 ↗
• MalfunctionAug 26, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, WHEN FLUSHING THE CLAMPED CATHETER, THE CATHETER PRESENTED A BALLOON ON THE ARTERIAL EXTENSION TUBE. IT WAS SAID THAT THE CATHETER HAD EXTRAVASATION/LEAK AND CRACK WHERE THE BALLOON FORMED. NO DAMAGE NOTED ON THE DEVICE PACKAGING. THE BOX THAT THE DEVICE CAME IN AND THE STERILE BARRIER WERE INTACT. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO FLUSHING. THE CLAMP WAS MOVED PERIODICALLY. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION WAS REQUIRED. NO MEDICAL INTERVENTION/TREATMENT PROVIDED DUE TO THE EVENT. CATHETER REPLACEMENT WAS DONE TO RESOLVE THE ISSUE (THEY PULLED OUT ANOTHER ONE) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12372409 ↗
• MalfunctionAug 3, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, BEFORE CATHETERIZATION, FLUSHING WAS DONE WITH A SUCCESSFUL OUTCOME. DURING THE PROCEDURE, THE GUIDE WIRE DID NOT PASS THROUGH THE ARTERIAL LUMEN OF THE CATHETER. THE CATHETER WAS REMOVED AND A NEW CATHETER WITH SIMILAR MODEL NUMBER WAS INSERTED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED, THERE WAS A <(><<)>2 ML (MILLILITER) OF BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. RE-CATHERIZATION WAS PERFORMED AS THE INTERVENTION/TREATMENT FOR THE EVENT, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, THERE WERE NO VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT, AND BETADINE WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THE CATHETER AND THE GUIDEWIRE THAT CAME WITH THE KIT WERE THE ONES BEING USED. THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT AND THE GUIDE WIRE WAS STILL INTACT WHEN IT WAS REMOVED. THE GUIDE WIRE AND CATHETER WAS REMOVED SIMULTANEOUSLY IN ONE ACTION. ALL PIECES WERE ACCOUNTED FOR AND NO EXCESSIVE FORCE USED TO PULL OUT THE GUIDE. THE DEVICE WAS NOT REPAIRED, THERE WAS NO LEAK, BETADINE AND CHLORHEXIDINE WAS USED ON THE DEVICE AS THE CLEANING AGENT. TEGO W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12266651 ↗
• MalfunctionMar 12, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING TREATMENT, THE CATHETER LEAKED BLOOD THROUGH THE BLUE EXTENSION TUBE. IT WAS SAID THAT THERE WAS A SMALL HOLE WHERE THE BLOOD LEAK CAME FROM. THE CATHETER WAS EXPLANTED AND REPLACED THE NEXT DAY TO SOLVE THE PROBLEM. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED. TREATMENT WAS NOT COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11473068 ↗
• MalfunctionJun 3, 2020Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem

  ACCORDING TO THE REPORTER, OOZING OF BLOOD DISCOVERED DURING DIALYSIS ON VENOUS PORT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10113538 ↗
• MalfunctionMar 11, 2019Break; Material Puncture/Hole; Break; Material Puncture/Hole

  ACCORDING TO THE REPORTER, AFTER THE REMOVAL OF THE DEVICE, IT WAS NOTICED THAT THERE WAS A BROKEN SURFACE ON THE LOWER PART OF THE CATHETER (ARTERIAL SIDE UNDER THE CLAMP). THE CATHETER REPAIRED AND WAS IMPLANTED TWICE THAT DAY BECAUSE THERE WAS A LEAKAGE AFTER THE FIRST TIME ON THE ARTERIAL SIDE. THERE WAS NO LUER ADAPTER ISSUE. CLEANING AGENTS USED WAS PHYSIOLOGICAL SODIUM (NACL) LIQUID AND FREKADERM SPRAY AS A DISINFECTANT FOR THE EXIT SITE. IN ORDER TO RESOLVE THE ISSUE, A NEW CATHETER WAS USED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8409393 ↗

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.