Palindrome non-Precision 8888541023Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521135482), received between Nov 13, 2017 and Aug 2, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

13 other recalls cover devices cleared under the same FDA submission (K111817); 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2021Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, PRIOR TO DIALYSIS TREATMENT, A HAIRLINE CRACKS AND LEAK WERE OBSERVED ON THE ARTERIAL (LUER ADAPTER) CONNECTOR. FLUSHING WAS DONE PRIOR TO USE AND LEAKAGE WAS DETECTED. CATHETER WAS REPAIRED IMMEDIATELY WITH REPAIR KIT AND DIALYSIS WAS MADE NORMAL AFTER REPAIR. THE REPAIRED CATHETER REMAINED IN PATIENT AND ONLY THE CONNECTORS WITH HAIRLINE CRACKS WILL BE RETURNED. THE DEVICE WAS USED SUCCESSFULLY AFTER IT WAS REPAIRED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS. OCTENISEPT ALCOHOL FREE WAS THE CLEANING AGENT USED ON THE DEVICE AND TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THERE WAS NO INTERVENTION/TREATMENT REQUIRED BUT ONLY REPAIR KIT WAS USED. THERE WAS NO TEGO UTILIZED. THERE WAS NO INSTRUMENT USED BUT ONLY HANDS TO LOOSEN OR TIGHTEN THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258601 ↗
• MalfunctionFeb 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE DOCTOR WAS CONNECTING THE HUB DURING INSERTION, THE SILICONE TUBING OF THE ONE BACK-END WAS DISCONNECTED. THE DOCTOR WAS THEN REQUESTED TO OPEN ANOTHER PACK TO CONNECT THE HUB WITH BACK-ENDS THAT WERE SECURELY FIT. IT WAS THAT THE DEVICE WAS USED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. FLUSHING WAS DONE PRIOR TO INSERTION AND THE RESULT WAS NORMAL. THERE WAS NO INTERVENTION OR TREATMENT DONE. THERE WAS NO BLOOD LOSS OR BLOOD TRANSFUSION REQUIRED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK AND NO TEGO UTILIZED. HIBITANE WAS THE CLEANING AGENT USED ON THE DEVICE AND ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO OTHER DEFECTS OR DAMAGES FOUND ON THE DEVICE PRIOR TO USE AND NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11331487 ↗
• MalfunctionOct 31, 2020Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT (AROUND ABOUT TWO HOURS AFTER CONNECTION AT THE DIALYZER), IT WAS SAID THAT A VERY LITTLE HAIR CRACK WAS OBSERVED ON THE BLUE LUER ADAPTER WITH BLOOD LEAKAGE. THE NURSE SAW IT BECAUSE THE PATIENT HAD A BLOOD DROP ON HER JACKET (SMALL BLOOD DROP, PATIENT DID NOT RECOGNIZE THAT THERE WERE BLOOD DROPS ON HER CLOTHES). NOTHING UNUSUAL WAS OBSERVED ASIDE FROM THE REPORTED ISSUE. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. OCTENISEPT WAS THE CLEANING AGENT USED ON THE DEVICE AND ALSO USED ON CLEANING THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE AS IT WAS TIGHTENED BY HANDS ONLY. THERE WAS A BLOOD LOSS OF MAXIMUM OF 50ML. NO BLOOD TRANSFUSION REQUIRED. NO MEDICAL INTERVENTION/TREATMENT PROVIDED DUE TO THE EVENT. TREATMENT WAS COMPLETED ON THE SAME DAY OF THE EVENT. IT WAS SAID THAT THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 10767274 ↗
• MalfunctionSep 24, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  ACCORDING TO THE REPORTER, THERE WAS A NEED TO REMOVE THE SUTURES OF THE DEVICE AFTER TEN WEEKS OF BEING IMPLANTED. IT WAS NOTED THAT THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, AND NO LUER ADAPTER ISSUE. IT WAS ALSO STATED THAT A12T 80% WAS USED AS A CLEANING AGENT OF THE DEVICE, TEGO WAS UTILIZED AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9112356 ↗
• MalfunctionSep 9, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THEY FOUND THE DEVICE LEAKING AND WAS BROKEN BELOW THE Y-PIECE, IT WAS ALSO STATED THAT THERE WAS A BLOOD LOSS. NOTHING UNUSUAL OBSERVED BEFORE USE AND THE PRODUCT WAS EXPLANTED, A NEW ACUTE CATHETER WAS IMPLANTED TO CONTINUE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8977998 ↗
• MalfunctionJul 29, 2019Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, PRIOR TO THE PROCEDURE (IMPLANTATION),THERE WAS DIFFICULTY INJECTING THE SALINE WATER AS THE CATHETER WAS SLIGHTLY BLOCKED. IT WAS ALSO FOUND THAT THERE WAS SOME LOOSE MATERIAL IN THE LUMEN. THE CATHETER WAS NEVER USED, AND IT WAS THEN DISCARDED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8836036 ↗
• MalfunctionMay 16, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  ACCORDING TO THE REPORTER, THE CATHETER HAD COME OUT FROM THE PATIENT AFTER THE CATHETER FIXATION HAD BEEN CONFIRMED AND THE SUTURES HAVE BEEN REMOVED. THEY HAD USED THE CATHETER FOR A LONG TIME AND THEY HAVE FOLLOWED THEIR NORMAL PROTOCOL IN THIS CASE. NO EXPLANATION COULD BE FOUND BY INTERVIEWING THE INVOLVED PHYSICIANS OR NURSES. THE ACCESS AND EXIT SITES WERE USED FOR THE FIRST TIME. CATHETER WAS IMPLANTED TWO (2) MONTHS AGO. SUTURES HAVE BEEN REMOVED FIVE (5) DAYS BEFORE THE CATHETER CAME OUT (MIGRATION ISSUE). THERE WAS NO LUER ADAPTER ISSUE AND HAD NO LEAKS. CLEANING AGENT WAS USED. CATHETER WAS NOT REPAIRED. SAFETY CAP WAS UTILIZED. INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO OTHER VISIBLE DAMAGE. NEW CATHETER WAS IMPLANTED TWO (2) DAYS AFTER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8617393 ↗
• MalfunctionOct 22, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS A LEAKAGE AND FISSURE AT THE BLUE CONNECTOR OF THE CATHETER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7991879 ↗
• MalfunctionOct 22, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, DURING USE, THERE WERE LEAKAGE AND FISSURE AT THE BLUE CONNECTOR OF THE PALINDROME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7991429 ↗
• MalfunctionNov 13, 2017Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, ON (B)(6) 2017, WHEN THE GAUZE BANDAGE WAS BEING REMOVED, THE DEVICE¿S PLASTIC Y-ADAPTER LOOSENED WITHOUT FORCE BEING APPLIED. A NEW Y-PIECE FROM ANOTHER CATHETER WAS USED IN ORDER TO RESOLVE THE ISSUE. THERE WAS NO MEDICAL INTERVENTION REQUIRED OR HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7025217 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111817. One submission often covers many models, so check the product and lot details in each record.

• Z-2360-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
• Z-2368-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
• Z-2367-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
• Z-2359-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
• Z-2363-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
• Z-2369-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
• Z-2366-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
• Z-2362-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044
• Z-2370-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
• Z-2365-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
• Z-2361-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
• Z-2358-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
• Z-2364-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119