Palindrome 8888145044Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10884521013247), received between Dec 11, 2017 and Aug 7, 2025 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

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

64 other recalls cover devices cleared under the same FDA submission (K112477); 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-1317-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Break; Break

  ACCORDING TO THE REPORTER, A CATHETER WAS USED AS THE ACCESS ROUTE FOR BLOOD WITHDRAWAL AND RETURN DURING HEMODIALYSIS, AND A CRACK WAS OBSERVED AT THE CENTRAL VENOUS END OF THE CHRONIC CATHETER. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCED USE ON THE DEVICE. THE CLEANING AGENT(S) ARE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. AS A REMEDIAL ACTION AND INTERVENTION, CLOSE MONITORING WAS CONDUCTED, AND THE CATHETER WAS SCHEDULED FOR REPLACEMENT. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. 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 22745861 ↗
• MalfunctionApr 2, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, ON THE SAME DAY AS THE PROCEDURE, AT THE COMPLETION OF THE CATHETERIZATION OPERATION, THE CATHETER REMAINED IN PLACE ONLY FOR THE LENGTH OF THE SURGERY. IT WAS FOUND THAT THE EXTENSION TUBE WAS BROKEN AT THE CLAMPING SITE, CAUSING LIQUID LEAKAGE. AFTER CAREFUL OBSERVATION, IT WAS FOUND THAT THE MIDDLE OF THE EXTENSION TUBE WAS RUPTURED, WITH BLOOD OOZING FROM THE BREAK. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE ISSUE DID NOT OCCUR WHEN THE CATHETER WAS CONNECTED TO THE MACHINE DURING A DIALYSIS TREATMENT. FLUSHING WAS DONE PRIOR TO USE, AND THE RESULT WAS NORMAL. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE CATHETER WAS NOT REPAIRED, AND IT WAS NOT REPLACED. NO CLEANING AGENT WAS USED ON THE DEVICE. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED WITH BETADINE PRIOR TO PRODUCT PLACEMENT. THE CLAMP WAS NOT MOVED PERIODICALLY. AS A REMEDIAL ACTION, THE CATHETER WAS REMOVED THE SAME DAY AS THE EVENT. THERE WAS A 3-5 ML (MILLILITERS) BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. REPLACING THE CATHETER WITH THE SAME BA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21758553 ↗
• MalfunctionMar 14, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING ROUTINE BETADINE DISINFECTION, A CRACK WAS OBSERVED AT THE VENOUS LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WAS A LEAK. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THE TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED. THE PROCEDURE WAS COMPLETED AFTER THE REMEDIAL ACTION. 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 21606153 ↗
• MalfunctionMar 2, 2025Break; Break

  ACCORDING TO THE REPORTER WITHIN ONE WEEK AFTER CATHETERIZATION, THE REPORTED CATHETER HAD AN OBVIOUS CRACK IN THE BLUE VENOUS ADAPTER WITH OOZING BLOOD LEAK. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICES. THERE WAS NO CLEANING AGENT USED ON THE DEVICE, AND TEGO WAS NOT UTILIZED. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501162 ↗
• MalfunctionMar 2, 2025Break; Break

  ACCORDING TO THE REPORTER DURING THE USE OF THE CATHETER, IT WAS OBSERVED THAT THE VENOUS LUER ADAPTER END HAD CRACKED, CAUSING BLOOD TO OOZE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE TEGO WAS NOT UTILIZED. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501161 ↗
• MalfunctionMar 2, 2025Break; Break

  ACCORDING TO THE REPORTER AFTER ONE WEEK USAGE OF DIALYSIS, VENOUS (BLUE) END LUER ADAPTER WAS CRACKED AND HAD LEAKED BLOOD. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO CLEANING AGENT WAS USED ON THE DEVICE. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501159 ↗
• MalfunctionMar 2, 2025Break; Break

  ACCORDING TO THE REPORTER, THE LUER ADAPTER WAS CRACKED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21501158 ↗
• MalfunctionMar 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING USE IT WAS OBSERVED THAT THE CATHETER VENOUS (BLUE) PORT HAD A CRACK. IT WAS ALSO STATED THAT THERE WAS A LEAK AT THE LUER ADAPTER. THE CATHETER WAS REPAIRED AND TEGO WAS NOT UTILIZED. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED WITH PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501152 ↗
• MalfunctionOct 22, 2024Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER WAS USED FOR MORE THAN ONE MONTH AND THE LUER ADAPTER (ARTERIAL) RUPTURED. THE CATHETER WAS REPAIRED. THERE WAS A LEAK AND CRACK OBSERVED IN THE RED (ARTERIAL) LUER ADAPTER. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE PRODUCT, AND THERE WAS NO CLEANING AGENT(S) USED ON THE PRODUCT. TEGO WAS NOT UTILIZED. THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506965 ↗
• MalfunctionOct 22, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING TREATMENT, THE CATHETER LUER ADAPTER WAS RUPTURED. THE CATHETER HAD BEEN PLACED FOR TWO MONTHS. THERE WAS A LEAK AND CRACK OBSERVED ON THE (RED) ARTERIAL PART OF THE LUER ADAPTER. NOTHING WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THE DIALYSIS PIPELINE WAS THE PRODUCT BEING UTILIZED WITH THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS EASILY REMOVED AND REPLACED. THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED FOR THE PATIENT DUE TO THE EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506724 ↗
• MalfunctionSep 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING USE, A CRACK WAS FOUND IN THE BLUE (VENOUS) LUER ADAPTER. THE CATHETER WAS REPAIRED. THERE WAS A LEAK AT THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. IODINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS DONE WITH A NORMAL RESULT. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. AS A REMEDIAL ACTION, THE CONNECTOR WAS REPLACED. THIS WAS ALSO THE INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT WAS PROCEEDED AND COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148099 ↗
• MalfunctionFeb 4, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHEN THE DOCTOR WAS PREPARING FOR THE PROCEDURE, THE PACKAGING OF THE CONSUMABLES WAS OPENED. THE CONSUMABLES WERE FLUSHED BEFORE THE PROCEDURE, AND A SMALL HOLE OR LEAK WAS FOUND ON THE SILICONE EXTENSION TUBE (EXTENSION TUBE AND BIFURCATION CONNECTION). IT WAS SAID THAT THE ISSUE WAS AT VENOUS (BLUE SIDE) OF THE EXTENSION TUBE. THERE WAS NO DAMAGE TO THE EXTERNAL PACKAGING AND NO DAMAGE TO THE DEVICE'S BOX. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. SALINE FLUSH WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO PROBLEM WITH THE LUER ADAPTER. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. TEGO WAS UTILIZED. THE CLAMPS MOVED TO A NEW LOCATION AFTER EACH TREATMENT. AS A REMEDIAL ACTION, A SET OF CONSUMABLES WAS REPLACED WITH SAME PRODUCT ID AND LOT TO COMPLETE THE PROCEDURE AT THE SAME DAY OF THE EVENT. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 18637625 ↗
• MalfunctionJan 30, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE SURGERY, BEFORE INSERTING INTO THE PATIENT, THE DOCTOR DISCOVERED THAT THERE WAS A BIFURCATION AT THE TIP OF THE GUIDE WIRE (TIP OF THE GUIDEWIRE WAS FRAYED). THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS THERE WAS A BIFURCATION AT THE TIP OF THE GUIDEWIRE. BESIDES THE REPORTED ISSUE THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CLEANING AGENT USED ON THE DEVICE WAS SALINE RINSE. THE INSERTION SITE WAS NOT TREATED WITH PRIOR TO PRODUCT PLACEMENT. TEGO WAS NOT UTILIZED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. AS A REMEDIAL ACTION THE REPORTED PRODUCT WAS IMMEDIATELY REPLACED WITH A NEW SET OF CONSUMABLES/SUPPLIES. THE CATHETER WAS REPLACED WITH A PRODUCT FROM THE SAME LOT AND PRODUCT ID ON THE SAME DAY OF THE EVENT. THE SURGERY WAS CONTINUED WITHOUT AFFECTING THE PATIENT'S TREATMENT OR PATIENT CARE. THE SURGERY WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18609008 ↗
• InjurySep 20, 2023Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT INTRACERVICAL TUNNELED CUFFED CATHETER (TCC) ON THE RIGHT NECK ON THE DAY OF THE EVENT, AND A RE-EXAMINATION OF THE CHEST RADIOGRAPH (POST-OPERATIVE CHEST X-RAY) SHOWED THAT THE CATHETER THAT WAS INCLUDED IN THE KIT WAS WRINKLED AFTER THE SURGERY. THE FLOW RATE DURING THE DIALYSIS PROCESS WAS STILL ACCEPTABLE. AT THAT TIME, IT WAS CONSIDERED WHETHER THERE WAS TISSUE OR FASCIA STRETCHING (TRACTION) THAT CAUSED THE CATHETER TO DEFORM. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. FLUSHING WAS DONE PRIOR TO USE WITH A NORMAL RESULT. TEGO WAS NOT UTILIZED, AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT REPAIRED. ON THE SECOND DAY AFTER THE SURGERY, THE CATHETER WAS ADJUSTED AGAIN TO RESOLVE THE ISSUE, AND THE FASCIA AND TISSUE AT THE DEFORMED PART WERE FULLY SEPARATED. AFTER IT WAS CONFIRMED THAT THE CATHETER WAS NOT STRET

  Patient problems: Unintended Radiation Exposure

  MAUDE report 17783386 ↗
• MalfunctionMay 11, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, BEFORE THE PROCEDURE, WHEN THE PHYSICIAN FLUSHED THE DEVICE, LEAKS IN THE SILICONE EXTENSION TUBE AND BIFURCATION CONNECTION WERE NOTICED. THE PROCEDURE WAS REPLACED WITH A NEW CATHETER SET. THERE WAS NO PROBLEM WITH THE LUER ADAPTER AND THE INSERTION SITE WAS NOT TREATED PRIOR TO USE. THE CATHETER WAS NOT REPAIRED AND TEGO WAS NOT UTILIZED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS A SMALL HOLE IN THE SILICONE EXTENSION TUBE AND THE LEAK WAS OBSERVED AT THE VENOUS SITE OF THE EXTENSION TUBE AND BIFURCATE CONNECTION. THERE WAS NO DAMAGE TO THE DEVICE EXTERNAL PACKAGING AND THE BOX THAT THE DEVICES CAME IN WAS NOT DAMAGED. THERE WAS NO CLEANING AGENT USED  ON THE DEVICE. THE CATHETER THAT CAME WITH THE KIT WAS THE ONE USED. REPLACING WITH ANOTHER SET OF CATHETER AND THE PROCEDURE WAS COMPLETED AFTER THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915808 ↗
• MalfunctionJan 10, 2023Break; Break

  ACCORDING TO THE REPORTER, BEFORE THE SURGERY, IT WAS FOUND THAT THERE WAS A CRACK AND LEAK AT THE JUNCTION OF THE HUB/BIFURCATE AND THE CATHETER SHAFT. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO DAMAGE TO THE OUTER PACKAGING, NO DAMAGE TO THE INNER PACKAGING, AND THE STERILE BARRIER WAS INTACT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS DONE PRIOR TO USE, WATER LEAKED, AND BESIDES THE REPORTED ISSUE THERE WERE NO OTHER DEFECTS/DAMAGES FOUND IN THE REPORTED PRODUCT AT THE TIME OF THE EVENT. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE, NO EXCESSIVE FORCE WAS USED, NO CLEANING AGENT WAS USED ON THE DEVICE, AND THE SITE DID NOT USE SEPSIDERM TO CLEAN THE CATHETER. TEGO WAS NOT UTILIZED. THE CATHETER WAS NOT REPAIRED. AS A REMEDIAL ACTION, THE REPORTED PRODUCT WAS REPLACED, AND ANOTHER PRODUCT WAS USED TO CONTINUE THE SURGERY. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS IN RELATION TO THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129671 ↗
• MalfunctionSep 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE CATHETER'S EXTENSION TUBE WAS DISLODGED. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15372623 ↗
• MalfunctionAug 4, 2021Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, PRIOR TO INSERTION, THE STYLETS WERE BLOCKED, IT COULD NOT FIT/GO THROUGH THE CATHETER BUT NO VISIBLE DEFECT/DAMAGE NOTED. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS THE SAME THAT OCCURRED ON STYLET, IT DID NOT FEED OR GO THROUGH THE CATHETER. THE CATHETER COULD NOT BE USED. A NEW CATHETER WAS OPENED AND USED TO RESOLVE THE ISSUE. IT WAS STATED THAT THE PROCEDURE WAS COMPLETED. HEPARIN SAUVE WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO BLOOD LOSS AND NO INTERVENTION/TREATMENT REQUIRED. THE STYLETS THAT WAS USED WERE THE ONES INCLUDED IN THE KIT. THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSION. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO PACKAGING DAMAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12275231 ↗
• MalfunctionJul 10, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT/DEVICE HAD A PUNCTURE NEAR AT THE EXIT SITE AND NEAR AT THE ULTEM LOCK ON THE SILICONE EXTENSIONS. IT WAS ALSO STATED THAT THERE WAS A CATHETER LEAK AND THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER WAS NOT REPAIRED, AND THEY HAD USED 2% OF CHLORHEXIDINE TO CLEAN THE DEVICE. THEY HAD TO REPLACE THE CATHETER WITH THE IDENTICAL REFERENCE NUMBER TO RESOLVE THE ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8776451 ↗
• MalfunctionJan 17, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, POST- OPERATIVELY, THERE WAS A LEAK AND A CRACK WAS OBSERVED IN THE RED (ARTERIAL) LUER ADAPTER. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7201791 ↗
• MalfunctionJan 17, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, DURING USE THERE WAS A LEAK AND A CRACK WAS OBSERVED IN THE RED (ARTERIAL) LUER ADAPTER. THE CATHETER WAS REPAIRED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7200892 ↗
• MalfunctionJan 17, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, DURING USE THERE WAS A LEAK IN THE VENOUS LUER ADAPTER DUE TO A CRACK. THE CATHETER WAS REPAIRED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7199815 ↗
• MalfunctionDec 11, 2017Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, WHILE UNDERGOING DIALYSIS, THE DEVICE LEAKED DUE TO A SMALL HOLE WHERE THE CATHETER TUBE MEETS THE BIFURCATE. THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Blood Loss

  MAUDE report 7105156 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112477. One submission often covers many models, so check the product and lot details in each record.

• Z-1319-2022 · Jun 8, 2022 · Open, Classified
  Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-1318-2022 · Jun 8, 2022 · Open, Classified
  Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-1891-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C
• Z-1894-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050
• Z-1873-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP
• Z-1906-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459
• Z-1893-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C
• Z-1898-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048P
• Z-1901-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049CP
• Z-1872-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064P
• Z-1857-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508
• Z-1883-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
• Z-1888-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
• Z-1905-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409
• Z-1853-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064

…and 49 more.