Palindrome 8888123409PRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521157804), received between Jun 8, 2018 and Apr 14, 2020 — classified as 1 death, 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 18, 2026.

Recalls naming this device

1. Apr 23, 2025Class IIOpen, Classified

   Potential breach of sterile barrier packaging.

   Z-1886-2025 · Root cause: Packaging · Recall details · FDA record ↗

2. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2020Break; Break

  ACCORDING TO THE REPORTER, IT WAS NOTED THAT THE CATHETER SHAFT (TUBE) HAD A LEAK JUST ABOVE THE WINGS/HUB. IT WAS STATED THAT THE CATHETER WAS NOT REPAIRED BUT WAS EXPLANTED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9956523 ↗
• MalfunctionFeb 12, 2020Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER WAS FOUND TO HAVE A LEAK IN THE CATHETER SHAFT. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LUER ADAPTER ISSUE, AND THERE WAS NO LEAK AT THE JUNCTION OF THE BIFURCATE AND CATHETER. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. CHG WAS THE CLEANING AGENT USED ON THE DEVICE. IT WAS ALSO STATED THAT THE CATHETER WAS NOT WORKING PROPERLY WHICH LED TO IMPROPER DIALYSIS TREATMENT AND CATHETER REPLACEMENT. THE CATHETER WAS REPLACED WITH ANOTHER PRODUCT (COMPETITOR'S PRODUCT). THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700727 ↗
• MalfunctionOct 10, 2018Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  ACCORDING TO THE REPORTER, THE CATHETER FELL OUT OF THE PATIENT AFTER THE SUTURES HAD BEEN REMOVED. AND THERE WERE BUBBLES ON THE SILVER ION SLEEVE BUT NO SIGNS OF INFECTION. CUSTOMER REPORTED THE SUTURES ON THE SECUREMENT WING HAD BEEN REMOVED AS A PROTOCOL. AND COMPETITOR¿S CATHETER WAS INSERTED TO RESOLVED THE ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952887 ↗
• MalfunctionOct 10, 2018Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER FELL OUT OF THE PATIENT, AND THERE WERE BUBBLES NOTED ON THE SILVER ION SLEEVE. IT WAS REPORTED THAT THE CATHETER FELL OUT AFTER THE SECUREMENT WING SUTURES HAD BEEN REMOVED AND THE REMOVAL OF THE SUTURES WAS THEIR REGULAR PROTOCOL. A NEW CATHETER WAS INSERTED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952816 ↗
• MalfunctionOct 10, 2018Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER FELL OUT OF THE PATIENT AFTER THE SUTURES HAD BEEN REMOVED. AND THERE WERE BUBBLES ON THE SILVER ION SLEEVE. THE SUTURES ON THE SECUREMENT WING HAD BEEN REMOVED AS A PROTOCOL, AND NEW CATHETER WAS INSERTED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952781 ↗
• MalfunctionSep 14, 2018Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER FELL OUT AND THERE WAS BUBBLING FOUND ON THE HEPARIN SILVER ION SLEEVE. A CUSTOMER REPORTED THAT THE CATHETER WAS SECURED WITH THE SUTURED WING, AND NEW CATHETER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7876597 ↗
• MalfunctionSep 14, 2018Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER FELL OUT EVEN SECUREMENT WING WAS USED. IT WAS INDICATED THERE WERE BUBBLES ON THE SILVER ION SLEEVE, AND NEW CATHETER WAS INSERTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7876563 ↗
• DeathAug 28, 2018Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER FELL OUT AND THERE WERE BUBBLING ON SILVER ION SHEATH. NO INTERVENTION WAS BEING DONE. IT WAS REPORTED THE CATHETER WAS SECURED VIA SUTURES AND TEGADERM. AND FOUR DAYS AFTER, THE PATIENT DIED DUE TO MULTIPLE COMORBIDITIES NOT RELATED TO THE PERFORMANCE OF THE CATHETER.

  Patient problems: Death

  MAUDE report 7824773 ↗
• MalfunctionJun 8, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  ACCORDING TO THE REPORTER, THE CATHETER FELL OUT. IT WAS STATED THAT THE TISSUE ATTENUATION INTO THE CUFF SEEMED TO BE DELAYED OR ABSENT. THE CATHETER WAS SECURED WITH SUTURES FOR AN EXTENDED PERIOD OF TIME BUT IN THIS SITUATION, IT WAS STATED THAT THE CUFF WAS CLEARLY EXPOSED. THE CATHETER WAS INSERTED AND WAS LATER REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7583210 ↗
• MalfunctionJun 8, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  ACCORDING TO THE REPORTER, THE CATHETER FELL OUT. IT WAS STATED THAT THE TISSUE ATTENUATION INTO THE CUFF SEEMED TO BE DELAYED OR ABSENT. THE CATHETER WAS SECURED WITH SUTURES FOR AN EXTENDED PERIOD OF TIME BUT IN THIS SITUATION, IT WAS STATED THAT THE CUFF WAS CLEARLY EXPOSED. THE CATHETER WAS INSERTED AND WAS LATER REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7583176 ↗
• MalfunctionJun 8, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  ACCORDING TO THE REPORTER, THE CATHETER FELL OUT. IT WAS STATED THAT THE TISSUE ATTENUATION INTO THE CUFF SEEMED TO BE DELAYED OR ABSENT. THE CATHETER WAS SECURED WITH SUTURES FOR AN EXTENDED PERIOD OF TIME BUT IN THIS SITUATION, IT WAS STATED THAT THE CUFF WAS CLEARLY EXPOSED. THE CATHETER WAS INSERTED AND WAS REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7582891 ↗
• MalfunctionJun 8, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  ACCORDING TO THE REPORTER, THE CATHETER FELL OUT. IT WAS STATED THAT THE TISSUE ATTENUATION INTO THE CUFF SEEMED TO BE DELAYED OR ABSENT. THE CATHETER WAS SECURED WITH SUTURES FOR AN EXTENDED PERIOD OF TIME BUT IN THIS SITUATION, IT WAS STATED THAT THE CUFF WAS CLEARLY EXPOSED. THE CATHETER WAS INSERTED AND REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7582885 ↗

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-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-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-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-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-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-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-0331-2016 · Oct 14, 2015 · Terminated
  Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for

…and 32 more.