Palindrome 8888145059PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521158290), received between Jul 13, 2021 and Jul 13, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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-1312-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2021Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT HAD A CATHETER PLACEMENT ON (B)(6). ON (B)(6), THE PATIENT STATED THAT WHEN SHE WAS AT HER RESIDENCE, THE CATHETER CAUGHT ON BLANKETS AND SHE PULLED IT OUT. THE NURSING HOME CALLED THE HOSPITAL TO TELL THEM AND SHE CAME INTHE NEXT DAY, (B)(6), TO HAVE IT REPLACED. BEFORE THE SURGERY, WHEN THE DOCTOR PALPATED THE CHEST OF THE PATIENT, HE COULD FEEL A PORTION OF THE CATHETER THAT WAS STILL PRESENT. THE DOCTOR WAS THINKING THAT THE CATHETER BROKE. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO BLOOD LEAKAGE FROM THE BROKEN CATHETER. THERE WAS NO BLOOD LOSS OR SYMPTOMS REPORTED AND NO BLOOD TRANSFUSION WAS REQUIRED. THERE WERE NO COMPLICATIONS. IT WAS SAID THAT AN X-RAY WAS DONE TO CHECK THE REMAINING PORTION OF THE CATHETER. THEN, THE DOCTOR PERFORMED A CUTDOWN (TO MAKE IT EASIER TO REMOVE) AND SURGICALLY REMOVED THE PORTION OF THE CATHETER (MOST OF IT ACTUALLY) AND REPLACED IT WITH A NEW ONE WITH ZERO ISSUES OR ADDITIONAL TREATMENTS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 12159129 ↗

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-1886-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision HSI 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-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-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-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-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-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-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
• 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-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 33 more.