Palindrome 8888145049PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521158177), received between Feb 13, 2020 and Oct 11, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 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-1315-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionOct 11, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER HAD A SMALL CRACK/TEAR IN THE TUBING JUST ABOVE THE CLAMP SITE. THE PRODUCT NEEDED TO BE REPLACED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12606105 ↗
• MalfunctionFeb 24, 2020Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING A CATHETER REPLACEMENT OF THE PATIENT'S DYSFUNCTIONAL LEFT JUGULAR TUNNELED CATHETER, THE BLUE SHEATH THAT GOES INTO THE CENTER OF THE LUMEN BROKE WHEN THE SURGEON TRIED TO REMOVE IT. ALL PIECES WERE REMOVED AND ACCOUNTED FOR. IT WAS ALSO MENTIONED THAT AFTER A THIRD ATTEMPT, A NEW DEVICE WAS INSERTED WITHOUT INCIDENT. A POST CHEST X-RAY WAS ORDERED AND SHOWED THAT THE DIALYSIS CATHETER TIP WAS PROJECTING OVER THE JUNCTION OF THE SUPERIOR VENA CAVA AND RIGHT ATRIUM. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Foreign Body In Patient

  MAUDE report 9743677 ↗
• MalfunctionFeb 13, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, AS THEY WERE READY TO PUT THE PATIENT ON DIALYSIS TREATMENT, THE CATHETER WAS NOTED TO HAVE A HOLE IN THE MIDDLE OF THE RED EXTENSION. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE. THERE WAS NO DAMAGE TO THE DEVICE'S BOX OR PACKAGING. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE AND THE CLAMP WAS MOVED PERIODICALLY. THEY DEVICE WAS LONGER USED. THEY HAD TO REPLACE THE LINE TO RESOLVE THE ISSUE AND THE DEVICE WAS USED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9706138 ↗

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-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-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-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-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-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-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-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-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-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-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.