Palindrome 8888145043CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521158061), received between Jul 15, 2022 and Mar 21, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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

48 other recalls cover devices cleared under the same FDA submission (K123196); 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-1313-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON (B)(6) 2025, THE CATHETER WAS CONNECTED TO THE DIALYSIS MACHINE IN REVERSE. THE ARTERIAL LINE (S UCTION) WAS MISTAKENLY CONNECTED TO THE BLUE CATHETER PATHWAY, AND THE VENOUS LINE (RETURN) TO THE RED CATHETER PATHWAY. AT THE START OF DIALYSIS, THE PATIENT EXPERIENCED ILLNESS DUE TO THE REVERSED CATHETER CONNECTION, WITH SYMPTOMS INCLUDING DIZZINESS, NAUSEA, A SORE THROAT, AND BREATHING DIFFICULTY. DESPITE NORMAL VITAL PARAMETERS¿BLOOD PRESSURE (BP) 140/81 MILLIMETERS OF MERCURY (MMHG), PULSE 80 BEATS PER MINUTE (BPM), GOOD HEMODYNAMICS, PERIPHERAL CAPILLARY OXYGEN SATURATION (SPO2) 99% ON AIR, AND RESPIRATORY RATE OF 12 BREATHS PER MINUTE¿THE PATIENT WAS NONPYRETIC (NO FEVER) AND VERY BRIEFLY LOST CONSCIOUSNESS, DESCRIBING A BLACKOUT SENSATION. DIALYSIS WAS STOPPED, AND THE PATIENT HAD BEEN DISCONNECTED. THE PATIENT RAPIDLY RECOVERED, WITH NO ABNORMAL MOVEMENTS. NEUROLOGICAL AND EAR, NOSE, AND THROAT (ENT) ASSESSMENTS WERE NORMAL, DESPITE THE PATIENT REPORTING A SWOLLEN THROAT SENSATION. ALL EXAMINATIONS HAD SHOWN NO ABNORMALITIES. THE PATIENT HAD A NORMAL GLASGOW OUTCOME SCALE (GOS) SCORE AND WAS NOTED TO HAVE RENAL ARTERY STENOSIS (RAS), WITH BLOOD E

  Patient problems: Dizziness; Dyspnea; Hypokalemia; Loss of consciousness; Malaise; Nausea; Sore Throat; Unintended Radiation Exposure

  MAUDE report 21662611 ↗
• MalfunctionJul 27, 2022Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER'S RED OR BLUE END HAD DEVELOPED A SPLIT/CRACK (BACK ENDS). THERE WAS NO AVAILABLE REPAIR KIT AND THE CATHETER REMAINED IN USE. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 15113543 ↗
• MalfunctionJul 27, 2022Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER'S RED OR BLUE END HAD DEVELOPED A SPLIT/CRACK (BACK ENDS). THERE WAS NO AVAILABLE REPAIR KIT AND THE CATHETER REMAINED IN USE. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 15113446 ↗
• MalfunctionJul 27, 2022Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER'S RED OR BLUE END HAD DEVELOPED A SPLIT/CRACK (BACK ENDS). THERE WAS NO AVAILABLE REPAIR KIT AND THE CATHETER REMAINED IN USE. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 15113077 ↗
• MalfunctionJul 15, 2022Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER'S RED OR BLUE END HAD DEVELOPED A SPLIT/CRACK (BACK ENDS). THERE WAS NO AVAILABLE REPAIR KIT AND THE CATHETER REMAINED IN USE. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 15026838 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123196. One submission often covers many models, so check the product and lot details in each record.

• Z-1887-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1889-2025 · Apr 23, 2025 · Open, Classified
  MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1888-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1885-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1886-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1635-2024 · Mar 15, 2024 · Open, Classified
  Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, aph
• Z-1634-2024 · Mar 15, 2024 · Open, Classified
  Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute a
• Z-1314-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
• Z-1315-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-1312-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
• Z-2375-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
• Z-2372-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
• Z-2371-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
• Z-2373-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
• Z-2374-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P

…and 33 more.