Palindrome 8888145062PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521158337), received between Feb 14, 2023 and Feb 14, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (3 reports).

49 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2023Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THERE WAS AN INSTANCE THAT WHERE THE CATHETER WAS NOT RUNNING ADEQUATELY ON THEIR HD (HEMODIALYSIS) MACHINE DUE TO HIGH PRESSURES OR CATHETER CLOTTING INTERNALLY AND HAVING TO BE CATHFLOWED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED AND THERE WAS NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS PERFORMED WITH NORMAL RESULT. THE CATHETER WAS PRONE TO CLOT, BUT WANTED TO BE SAFE, SO IT WAS REPORTED. THIS WAS THE FIRST TIME THAT THIS TYPE OF CATHETER (SILVER ION COATED) WAS PLACED AT THIS FACILITY, AS THEY HAVE BEEN USING COMPETITOR'S BRAND. THEY HAVE USED FEW OF OUR CATHETERS BEFORE AND NO TROUBLE WAS REPORTED. THEY USED TEGO CAPS AND LOCK WITH SALINE AND THE CATHETER CAN BE PRONE TO CLOT. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE TREATMENT WAS COMPLETED AND THE BLOOD OF THE PATIENT WAS SAFELY RETURNED. IT WAS ALSO STATED THAT CATHFLO WAS THE A NTICOAGULANT, AND CATHFLOW WAS PROVIDED AS THE INTERVENTION/TREATMENT FOR THE INTERNAL CATHETER CLOTTING. IT WAS ALSO MENTIONED THAT CATHFLOW WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16374782 ↗
• MalfunctionFeb 14, 2023Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THERE WAS AN INSTANCE THAT WHERE THE CATHETER WAS NOT RUNNING ADEQUATELY ON THEIR HD (HEMODIALYSIS) MACHINE DUE TO HIGH PRESSURES OR CATHETER CLOTTING INTERNALLY AND HAVING TO BE CATHFLOWED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED AND THERE WAS NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS PERFORMED WITH NORMAL RESULT. THE CATHETER WAS PRONE TO CLOT, BUT WANTED TO BE SAFE, SO IT WAS REPORTED. THIS WAS THE FIRST TIME THAT THIS TYPE OF CATHETER (SILVER ION COATED) WAS PLACED AT THIS FACILITY, AS THEY HAVE BEEN USING COMPETITOR'S BRAND. THEY HAVE USED FEW OF OUR CATHETERS BEFORE AND NO TROUBLE WAS REPORTED. THEY USED TEGO CAPS AND LOCK WITH SALINE AND THE CATHETER CAN BE PRONE TO CLOT. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE TREATMENT WAS COMPLETED AND THE BLOOD OF THE PATIENT WAS SAFELY RETURNED. IT WAS ALSO STATED THAT CATHFLO WAS THE ANTICOAGULANT, AND CATHFLOW WAS PROVIDED AS THE INTERVENTION/TREATMENT FOR THE INTERNAL CATHETER CLOTTING. IT WAS ALSO MENTIONED THAT CATHFLOW WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16374585 ↗
• MalfunctionFeb 14, 2023Insufficient Flow or Under Infusion; Defective Component; Obstruction of Flow; Insufficient Flow or Under Infusion; Defective Component; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THERE WAS AN INSTANCE THAT WHERE THE CATHETER WAS NOT RUNNING ADEQUATELY ON THEIR HD (HEMODIALYSIS) MACHINE DUE TO HIGH PRESSURES OR CATHETER CLOTTING INTERNALLY AND HAVING TO BE CATHFLOWED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED AND THERE WAS NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS PERFORMED WITH NORMAL RESULT. THE CATHETER WAS PRONE TO CLOT, BUT WANTED TO BE SAFE, SO IT WAS REPORTED. THIS WAS THE FIRST TIME THAT THIS TYPE OF CATHETER (SILVER ION COATED) WAS PLACED AT THIS FACILITY, AS THEY HAVE BEEN USING COMPETITOR'S BRAND. THEY HAVE USED FEW OF OUR CATHETERS BEFORE AND NO TROUBLE WAS REPORTED. THEY USED TEGO CAPS AND LOCK WITH SALINE AND THE CATHETER CAN BE PRONE TO CLOT. IT WAS MENTIONED THAT THE CATHETER HAD INCORRECT LENGTH AND HAD TO GET A CATHETER EXCHANGE, BUT THAT WAS NOT A CATHETER ISSUE. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATION ASSOCIATED WITH THIS EVENT. THE TREATMENT WAS COMPLETED AND THE BLOOD OF THE PATIENT WAS SAFELY RETURNED. IT WAS A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16374357 ↗

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-1889-2025 · Apr 23, 2025 · Open, Classified
  MAHURKAR 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-1887-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision SI 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-1888-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision H 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-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-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-1313-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
• 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-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-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

…and 34 more.