Palindrome 8888145043Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10884521013223), received between Jun 8, 2018 and Nov 12, 2025 — classified as 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “Break” (33 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Break; Break

  ACCORDING TO THE REPORTER, BEFORE THE PATIENT WAS DIALYZED, A CRACK, BREAK AND LEAK WERE OBSERVED IN THE RED (ARTERIAL) LUER ADAPTER. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE TYPE OF CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR. THE PHYSICIAN WAS CONTACTED TO REPLACE THE LUER. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532826 ↗
• InjurySep 18, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT WAS TRANSFERRED FROM THE LOCAL HOSPITAL AND ADMITTED TO THE REPORTING FACILITY, WHERE A CRACK AT THE VENOUS END OF THE LONG-TERM CATHETER WAS DISCOVERED DURING EXAMINATION AND IDENTIFIED AS THE LOCATION OF THE LEAK. THE DIALYSIS LINE (BLOODLINE OR TUBING) AT THE DIALYSIS CENTER DID NOT FIT (INCOMPATIBLE) INTO THE LONG-TERM CATHETER, AND EXCESSIVE FORCE DURING THE CONNECTION PROCESS CAUSED A CRACK IN THE VENOUS END OF THE LONG-TERM CATHETER. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. AFTER REPLACING THE VENOUS CATHETER TIP, DIALYSIS WAS SUCCESSFULLY RESUMED WITHOUT ISSUES. THE CATHETER WAS REPAIRED ON THE SAME DAY. THE ENTIRE CATHETER WAS NOT REMOVED. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088697 ↗
• MalfunctionSep 9, 2025Break; Break

  ACCORDING TO THE REPORTER, THREE DAYS PRIOR TO ADMISSION, DURING DIALYSIS AT THE LOCAL HOSPITAL¿S DIALYSIS UNIT, THE CATHETER HAD VENOUS END BLOOD LEAKAGE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. AFTER REVERSING THE CONNECTION AS AN INTERVENTION, DIALYSIS PROCEEDED NORMALLY. THERE WAS AN UNSPECIFIED AMOUNT OF BLOOD LOSS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 23002058 ↗
• MalfunctionAug 18, 2025Break; Break

  ACCORDING TO THE REPORTER, A CRACK AND LEAK WERE OBSERVED AT THE BLUE (VENOUS) LUER ADAPTER. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. 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 22828802 ↗
• MalfunctionAug 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING NORMAL USE, THE VENOUS END CATHETER WAS BROKEN AND CONTINUOUSLY OCCURRED IN THE SAME PATIENT. THERE WAS NO LEAK. NO CLEANING AGENT WAS USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS A CRACK AT THE LUER ADAPTER. NO INSTRUMENTS WERE 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 22826885 ↗
• MalfunctionAug 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING NORMAL USE, THE CATHETER VENOUS END WAS BROKEN. THE CATHETER WAS NOT REPAIRED. THERE WAS A LEAK AND CRACK AT THE BLUE (VENOUS) LUER ADAPTER. NO INSTRUMENTS WERE USED TO LOOSEN OR TIGHTEN THE DEVICE. NO CLEANING AGENT WAS USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826697 ↗
• MalfunctionAug 14, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING NORMAL USE, THE CATHETER¿S VENOUS END WAS RUPTURED. THE CATHETER WAS NOT REPAIRED. THERE WAS A LEAK AND CRACK AT THE BLUE (VENOUS) ADAPTER. NO INSTRUMENTS WERE USED TO LOOSEN OR TIGHTEN THE DEVICE. NO CLEANING AGENT WAS USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809230 ↗
• MalfunctionAug 11, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING NORMAL USE, A CRACK AND LEAK WERE OBSERVED IN THE BLUE (VENOUS) LUER ADAPTER. IT WAS ALSO STATED THAT THE LUER ADAPTER DETACHED. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE, AND A TEGO WAS NOT UTILIZED. 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 22772401 ↗
• MalfunctionAug 11, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING NORMAL USE, A CRACK AND LEAK WERE OBSERVED IN THE BLUE (VENOUS) LUER ADAPTER. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE, AND A TEGO WAS NOT UTILIZED. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772147 ↗
• MalfunctionJul 22, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A PRE-DIALYSIS ASSESSMENT OF THE CATHETER, AND IT WAS FOUND THAT THE VENOUS LUER CONNECTOR OF THE CATHETER HAD A CRACK. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE ASIDE FROM THE ISSUE. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22571821 ↗
• MalfunctionJul 15, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A PRE-DIALYSIS VASCULAR ACCESS ASSESSMENT, AND CRACKS WERE REVEALED AT BOTH THE ARTERIAL AND VENOUS LUER CONNECTORS OF THE CATHETER. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. NO EXCESSIVE FORCED USE ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENT(S) ARE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. 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 22507683 ↗
• MalfunctionJul 15, 2025Break; Break

  ACCORDING TO THE REPORTER, BEFORE TREATMENT, THE PATIENT UNDERWENT A PRE-DIALYSIS VASCULAR ACCESS ASSESSMENT, AND CRACKS WERE REVEALED AT BOTH THE ARTERIAL AND VENOUS LUER CONNECTORS OF THE CATHETER. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. NO EXCESSIVE FORCED USE ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENT(S) ARE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22507141 ↗
• MalfunctionJul 11, 2025Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO THE DIALYSIS SESSION, DURING FLUSHING, A CRACKED LUER ADAPTER WAS OBSERVED. THERE WAS NO LEAK. THE TYPE OF CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR. IODOPHOR WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE ADAPTERS, AND THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENTS TO THE AREA. A TEGO WAS NOT UTILIZED. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THE INSERTION SITE WAS NOT TREATED WITH ANYTHING PRIOR TO PRODUCT PLACEMENT. THE METHOD UTILIZED TO TIGHTEN THE ADAPTERS WAS BY HAND. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NOTHING ELSE UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, AND THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT. THE REMEDIAL ACTION PERFORMED TO ADDRESS THE ISSUE WAS REPLACING THE WHOLE CATHETER, AND THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS AS A RESULT OF THE EVENT, AND NO BLOOD TRANSFUSION WAS REQUIRED. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22481445 ↗
• MalfunctionJul 10, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS PREPARATION, A RUPTURED CONNECTOR WAS OBSERVED. THE CATHETER WAS REPAIRED. THERE WAS A LEAK. TEGO WAS NOT UTILIZED. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472196 ↗
• MalfunctionJun 30, 2025Break; Break

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THERE WAS A CRACK AND LEAK AT THE BLUE (VENOUS) LUER CONNECTOR. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22360810 ↗
• MalfunctionMay 28, 2025Break; Break

  ACCORDING TO THE REPORTER, IT WAS FOUND THAT THE CATHETER'S LUER ADAPTER HAD A CRACK. THE CATHETER WAS NOT REPAIRED, AND THERE WAS NO LEAK. NO CLEANING AGENT WAS USED ON THE DEVICE. A TEGO WAS NOT UTILIZED. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE INITIAL DISPOSITION INVOLVED REPLACING THE PATIENT'S VASCULAR ACCESS CATHETER WITH A PRODUCT USING THE SAME LOT AND ID (IDENTIFIER). THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094056 ↗
• MalfunctionMay 27, 2025Break; Break

  ACCORDING TO THE REPORTER, HEMODIALYSIS CATHETERS WITH TUNNELED POLYESTER SLEEVES ARE SEMI-PERMANENT VASCULAR ACCESS. SERVICE LIFE WAS TYPICALLY 1-3 YEARS. THE CATHETERIZATION TIME OF THIS PATIENT WAS (B)(6) 2024, AT THE HOSPITAL. THE CATHETER LUER ADAPTER CRACK OCCURRED AND WAS FOUND ON (B)(6) 2025, IN THE HEMODIALYSIS ROOM. THE PRELIMINARY ANALYSIS WAS THAT THE PRODUCT HAD A QUALITY ISSUE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. 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 REPORTED PRODUCT WAS REPLACED WITH THE SAME LOT AND ID. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092764 ↗
• MalfunctionApr 24, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING PREPARATION FOR DIALYSIS, THE BLUE (VENOUS) ADAPTER WAS FOUND TO BE BROKEN/CRACKED. THE CATHETER WAS REPAIRED. THERE WAS A LEAK AT THE LUER ADAPTER. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. IODINE/IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900374 ↗
• MalfunctionApr 17, 2025Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  ACCORDING TO THE REPORTER, DURING DIALYSIS, A FLUID LEAKAGE OCCURRED, AND A CRACK WAS OBSERVED AT THE VENOUS LUER ADAPTER. THE CATHETER HAS BEEN IN PLACE FOR FOUR MONTHS. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. 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. FLUSHING WAS DONE PRIOR TO USE. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THE TEGO WAS NOT UTILIZED. IODINE WAS THE CLEANING AGENT USED ON THE DEVICE. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED BY REPLACING THE ADAPTER USING A REPAIR KIT. THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER THE REMEDIAL ACTION WAS PERFORMED. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856529 ↗
• MalfunctionApr 16, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS, FLUID LEAKAGE WAS FOUND, AND CRACKS WERE OBSERVED ON THE SURFACE OF THE BLUE (VENOUS) ADAPTER END. THE CATHETER WAS REPAIRED BY REPLACING THE DAMAGED ADAPTER. IODINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE CRACK WAS VISIBLE TO THE NAKED EYE, AND NO OTHER INSTRUMENT WAS USED ON THE ADAPTER SURFACE TO LOOSEN OR TIGHTEN THE DEVICE. TUBING WAS USED TO CONNECT THE LUER ADAPTER. THERE WAS AN UNUSUAL OBSERVATION ON THE DEVICE'S ADAPTER, AS IT WAS BROKEN AFTER CONNECTING THE TUBING PRIOR TO USE. FLUSHING WAS DONE BEFORE USE, AND THERE WAS A LITTLE LIQUID LEAKAGE. DOMESTIC TUBING WAS ANOTHER PRODUCT BEING UTILIZED WITH THE DEVICE. BETADINE WAS THE CLEANING AGENT TYPICALLY USED TO CLEAN THE ADAPTERS. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. THE CATHETER WAS IN PLACE FOR 3 MONTHS. AS REMEDIAL ACTIONS, THE BROKEN ADAPTER WAS REPLACED, AND THE REPORTED CATHETER WAS REPLACED WITH THE SAME LOT AND ID (IDENTIFIER) ON THE SAME DAY. THE CATHETER COULD BE USED NORMALLY, AND SUBSEQUENT DIALYSIS TREATMENT WAS C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21851681 ↗
• MalfunctionMar 21, 2025Break; Break

  ACCORDING TO THE REPORTER, THE CRACK WAS FOUND AT THE RED END ADAPTER. THE CATHETER WAS NOT REPAIRED. THERE WAS A LEAK AND CRACK AT THE RED (ARTERIAL) LUER ADAPTER. NO INSTRUMENTS WERE 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. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. THE CATHETER WAS NOT REPLACED. CLEANING AGENT(S) WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. THERE WAS NO REMEDIAL ACTION TAKEN TO RESOLVE THE ISSUE. THE REPORTED PRODUCT WAS NOT REPLACED. THE TREATMENT WAS COMPLETED. HAND WAS THE METHOD USED TO TIGHTEN THE ADAPTERS. NO MEDICAL INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO R EPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662736 ↗
• MalfunctionMar 14, 2025Break; Break

  ACCORDING TO THE REPORTER, A CRACK WAS OBSERVED IN THE BLUE (VENOUS) LUER ADAPTER. THE CATHETER WAS REPAIRED. THERE WAS A LEAK AT THE LUER ADAPTER. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. NO INSTRUMENTS WERE USED TO LOOSEN OR TIGHTEN THE DEVICE. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. BETADINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED WITH NORMAL SURGICAL SKIN PREPARATION (BETADINE DISINFECTION) PRIOR TO PRODUCT PLACEMENT. HAND WAS THE METHOD USED TO TIGHTEN THE ADAPTERS. THE TREATMENT WAS COMPLETED. NO MEDICAL INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. 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 21607107 ↗
• MalfunctionMar 14, 2025Break; Break

  ACCORDING TO THE REPORTER, A CRACK WAS OBSERVED IN THE BLUE (VENOUS) LUER ADAPTER. THE CATHETER WA S REPAIRED. THERE WAS A LEAK. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. NO INSTRUMENTS WERE USED TO LOOSEN OR TIGHTEN THE DEVICE. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. BETADINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED WITH NORMAL SURGICAL SKIN PREPARATION (BETADINE DISINFECTION) PRIOR TO PRODUCT PLACEMENT. HAND WAS THE METHOD USED TO TIGHTEN THE ADAPTERS. THE TREATMENT WAS COMPLETED. NO MEDICAL INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. 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 21606418 ↗
• MalfunctionMar 14, 2025Break; Break

  ACCORDING TO THE REPORTER, THERE WERE CRACKS IN THE BLUE SECTION OF THE NOZZLE OR THE TUBE OPENING. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE PRODUCT WAS REPLACED WITH THE SAME PRODUCT ID (IDENTIFIER) AND LOT. THEY REPORTED THE ADVERSE EVENT AND HAD THE CARRIER CONTACT THE MANUFACTURER AS THE INITIAL DISPOSITION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606006 ↗
• MalfunctionMar 3, 2025Break; Break

  ACCORDING TO THE REPORTER DURING HEMODIALYSIS, IT WAS FOUND THAT THE RED LUER CONNECTOR OF THE CATHETER DIALYSIS TUBE HAD RUPTURED/CRACKED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS PERFORMED WITH NORMAL RESULTS. ASIDE FROM THE REPORTED ISSUE, NO OTHER DAMAGE WAS FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. NO OTHER PRODUCTS WERE BEING UTILIZED. NO EXCESSIVE FORCE WAS APPLIED, AND THE CLAMP WAS MOVED PERIODICALLY. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED, AND THE CONNECTOR WAS REPLACED WITH ANOTHER ONE OF THE SAME PRODUCT ID ON THE SAME DAY AS THE EVENT, AND THE TREATMENT WAS COMPLETED. A REPAIR KIT WAS NOT USED. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS PERFORMED. NO MEDICAL INTERVENTION WAS REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501959 ↗

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-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-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-1872-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064P
• Z-1878-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P
• Z-1850-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion.
• 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-1866-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066
• Z-1890-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145048
• Z1856-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458
• Z1855-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408
• Z-1871-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063CP
• Z-1857-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508
• Z-1891-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C
• Z-1892-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049
• Z-1902-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P

…and 49 more.