Palindrome 8888541028Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521135499), received between Oct 22, 2018 and Apr 6, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, 1 YEAR AND 8 MONTHS AFTER THE CATHETER WAS INSERTED, ON THE NIGHT OF 11TH TO 12TH OF MARCH, THE PATIENT WOKE UP AT HOME WITH CLOTHING SOAKED IN BLOOD. THERE WAS A LEAK FROM THE EXIT SITE, BLEEDING WAS PERSISTENT, AND IT WAS DIFFICULT TO QUANTIFY. CLAMPING WAS DONE BY PARAMEDICS ON ARRIVAL AFTER ABOUT 30 MINUTES AND THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM. THE PATIENT WAS IN STABLE CONDITION ON ARRIVAL. THE CATHETER WAS REPAIRED IN THE DIALYSIS WARD ON THE DAY OF THE EVENT. THE PATIENT WAS IN GOOD CLINICAL CONDITION. BLOOD TRANSFUSION WAS NOT REQUIRED. NOTHING UNUSUAL OBSERVED ON THE DEVICE BEFORE THE EVENT OCCURRED. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE ASIDE FROM THOSE USED FOR DIALYSIS. TEGO WAS UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. CHLORHEXIDINE WAS THE CLEANING AGENT USED ON THE DEVICE. THE WOUND DRESSING DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE. THE CLEANING AGENT HAD NEVER SWITCHED OVER THE LIFE OF THE CATHETER. THE CLEANING AGENT HAD NEVER MIXED. THE SITE HAD NEVER USED SEPSIDERM TO CLEAN CATHETERS. THERE WAS NO PROTOCOL CHANGE FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617520 ↗
• 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 Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7992863 ↗
• 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 Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7991980 ↗
• MalfunctionOct 22, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS A LEAKAGE AND FISSURE AT THE BLUE CONNECTOR OF THE CATHETER. IT WAS STATED THAT A TEGO WAS UTILIZED AND THE ADAPTER WAS TIGHTENED BY HAND. THE OLD CONNECTOR WAS REMOVED AND A NEW KIT'S CONNECTOR WAS USED. OCTENISEPT WAS USED AS A CLEANING AGENT TO CLEAN THE ADAPTER AND THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENTS TO THE AREA. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 7991964 ↗
• 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 7991912 ↗

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-2365-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
• 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-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-2364-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
• 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-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-2369-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
• 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-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-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-2366-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
• Z-2367-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133