Palindrome 8888119365PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521157712), received between Aug 15, 2022 and Aug 15, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

47 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 16, 2026.

Recalls naming this device

1. Apr 23, 2025Open, Classified

   Potential breach of sterile barrier packaging.

   Z-1888-2025 · Root cause: Packaging · Recall details · FDA record ↗

2. Jun 8, 2022Open, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2022Insufficient Flow or Under Infusion; Defective Component; Insufficient Flow or Under Infusion; Defective Component

  ACCORDING TO THE REPORTER, A NEW CVC (CENTRAL VENOUS CATHETER) WAS PLACED IN ON (B)(6)2022. IT WAS SAID THAT THERE WAS A SUPPLY ISSUE WITH HD (HEMODIALYSIS) TREATMENT ON (B)(6)AND AGAIN ON (B)(6). "PS" WAS AROUND 240. CVC WAS ON RECALL. IT WAS SAID THAT THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. IT WAS NOTED THAT AS THE MANUFACTURER HAD SENT OUT A RECALL ON THIS CATHETER WITH THE AFFECTED LOT NUMBER AND AFTER DISCUSSION WITH "MRHP", A CVC EXCHANGE ORDER/PROCEDURE WAS RECEIVED AND SCHEDULED WITHIN A WEEK. IT WAS SAID THAT THE IMPACT OF THE INCIDENT WAS, "TPA" WAS ORDERED ON (B)(6). THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15227015 ↗
• MalfunctionAug 15, 2022Insufficient Flow or Under Infusion; Defective Component; Insufficient Flow or Under Infusion; Defective Component

  ACCORDING TO THE REPORTER, A NEW CVC (CENTRAL VENOUS CATHETER) WAS PLACED IN (B)(6) 2022. IT WAS SAID THAT THERE WAS A SUPPLY ISSUE WITH HD (HEMODIALYSIS) TREATMENT ON JUNE 14 AND AGAIN ON JUNE 21. "PS" WAS AROUND 240. CVC WAS ON RECALL. IT WAS SAID THAT THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. IT WAS NOTED THAT AS THE MANUFACTURER HAD SENT OUT A RECALL ON THIS CATHETER WITH THE AFFECTED LOT NUMBER AND AFTER DISCUSSION WITH "MRHP", A CVC EXCHANGE ORDER/PROCEDURE WAS RECEIVED AND SCHEDULED WITHIN A WEEK. IT WAS SAID THAT THE IMPACT OF THE INCIDENT WAS, "TPA" WAS ORDERED ON JUNE 21. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15226854 ↗

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-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-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-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-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-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-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-0330-2016 · Oct 14, 2015 · Terminated
  Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic he

…and 32 more.