Palindrome 8888145048PRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521158153), received between Nov 20, 2017 and Oct 31, 2023 — classified as 3 deaths, 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2023Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, WHILE INSERTING TO THE PATIENT (CATHETER WITH GUIDE WIRE AND VENATRAC), THE GUIDE WIRE THAT WAS INCLUDED ON THE REPORTED KIT OPENED AT THE DISTAL END (GUIDE WIRE UNRAVELED). THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO LEAK OBSERVED AT THE TIME OF THE EVENT. THERE WAS NO DAMAGE TO THE OUTER PACKAGING AND INNER PACKAGING. THE STERILE BARRIER WAS INTACT. THERE WAS NOTHING UNUSUAL OBSERVE ON THE DEVICE PRIOR TO OPENING THE PACKAGE AND PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE AND THERE WAS NO PROBLEM. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE INSERTION SITE WAS TREATED WITH CLORHEX PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENT USED ON THE DEVICE WAS ¿CORHEXIDINA¿. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. THE GUIDEWIRE WAS REMOVED BY HAND AND THERE WERE NO TOOLS USED WHEN TRYING TO REMOVE THE GUIDEWIRE. IT WAS STATED THAT IT WAS NECESSARY TO REMOVE THE GUIDE WIRE AND CATHETER FROM THE PATIENT SIMULTANEOUSLY (IN ONE ACTION) DUE TO THE ALLEGED DEFECT. WHEN REMOVED THE GUIDEWIRE WAS STILL INTACT (DID NOT BREAK APART). AS A REMEDIAL ACTION THE REPORTED PRODUCT WAS CHANGED. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18041690 ↗
• DeathAug 29, 2022Defective Component; Adverse Event Without Identified Device or Use Problem; Defective Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS ADMITTED PRIOR TO DIAGNOSIS OF CLABSI, PERM HD CATHETER WAS INSERTED AND PATIENT HAD BEEN IDENTIFIED TO HAVE A CENTRAL LINE ASSOCIATED BLOOD STREAM INFECTION (CLABSI) OR CATHETER ASSOCIATED INFECTION, THE TYPE OF INFECTION THE PATIENT HAD WAS CLOSTRIDIOSES DIFFICILE AND BACTEREMIA. THE SEAL ALERT REGARDING RECALL OF AFFECTED CATHETERS WAS RECEIVED ON 7/8/2022, ALERT STATED THAT THE COMPANY HAD IDENTIFIED POTENTIAL LEAKING AT THE HUB AND RECALLED THE AFFECTED DEVICES BUT IT WAS STATED THAT THERE WAS NO REPORT OF LEAKING OR OTHER SPECIFIC CATHETER ISSUES ASIDE FROM THE INFECTION. THERE WAS NO LEAK AND THERE WAS NO LUER ADAPTER ISSUE. TEGO WAS UTILIZED. ALCOHOL PAD WAS THE CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS TREATED WITH CHLORAPREP (DURAPREP FOR IODINE ALLERGY) PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS DONE WITH NO ABNORMALITIES NOTED AND CLEAR GUARD AND TEGOS WERE UTILIZED WITH THE DEVICE. THERE WERE NO DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE CATHETER REMAINED IN USE FOR ONGOING DIALYSIS TREATMENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Encephalopathy; Fever; Septic Shock

  MAUDE report 15312650 ↗
• InjuryAug 9, 2022Nonstandard Device

  PATIENT ADMITTED (B)(6) 2022. PERM HD CATHETER INSERTED (B)(6) 2022. SEAL ALERT REGARDING RECALL OF AFFECTED CATHETERS FROM MEDTRONIC RECEIVED 7/8/2022 WITH COMPLIANCE END DATE OF 7/22/2022. ALERT STATES THAT MEDTRONIC HAS IDENTIFIED POTENTIAL LEAKING AT THE HUB AND RECALLS THE AFFECTED DEVICES. PATIENT SUSPECTED TO HAVE A CENTRAL LINE ASSOCIATED BLOOD STREAM INFECTION (CLABSI) WITH DATE OF EVENT (B)(6) 2022. PERM HD CATHETER REMOVED (B)(6) 2022 AND CATHETER TIP SENT FOR CULTURE. (B)(6) 2022: POSITIVE 4/4 BOTTLES MRSA (B)(6) 2022: POSITIVE CATH TIP: >100 COLONY FORMING UNITS MRSA (B)(6) 2022: POSITIVE 2/4 BOTTLES (B)(6) 2022: POSITIVE 2/4 BOTTLES MRSA. FDA SAFETY REPORT ID #(B)(4).

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 15198319 ↗
• DeathAug 8, 2022Nonstandard Device

  PATIENT ADMITTED (B)(6) 2022. PERM HD CATHETER INSERTED (B)(6) 2022. SEAL ALERT REGARDING RECALL OF AFFECTED CATHETERS FROM MEDTRONIC RECEIVED 7/8/2022. ALERT STATES THAT MEDTRONIC HAS IDENTIFIED POTENTIAL LEAKING AT THE HUB AND RECALLS THE AFFECTED DEVICES. PATIENT IDENTIFIED TO HAVE A CENTRAL LINE ASSOCIATED BLOOD STREAM INFECTION (CLABSI) WITH DATE OF EVENT (B)(6) 2022. PATIENT THEN EXPIRED (B)(6) 2022 WITH AFFECTED LINE IN PLACE AND IN USE. POSITIVE 2/4 BOTTLES ENTEROCOCCUS FAECIUM. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15192156 ↗
• DeathAug 8, 2022Nonstandard Device

  PATIENT ADMITTED (B)(6) 2022. PERM HD CATHETER INSERTED (B)(6) 2022. SEAL ALERT REGARDING RECALL OF AFFECTED CATHETERS FROM MEDTRONIC RECEIVED 7/8/2022. ALERT STATES THAT MEDTRONIC HAS IDENTIFIED POTENTIAL LEAKING AT THE HUB AND RECALLS THE AFFECTED DEVICES. PATIENT IDENTIFIED TO HAVE A CENTRAL LINE ASSOCIATED BLOOD STREAM INFECTION (CLABSI) WITH DATE OF EVENT (B)(6) 2022. PATIENT THEN EXPIRED (B)(6) 2022 WITH AFFECTED LINE IN PLACE AND IN USE. POSITIVE 2/4 BOTTLES ENTEROCOCCUS FAECALIS. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15192147 ↗
• 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 7583357 ↗
• 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 THE CUFF WAS CLEARLY EXPOSED. THE CATHETER WAS INSERTED AND WAS REMOVED. IT WAS ALSO STATED THAT THE CATHETER WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7583131 ↗
• MalfunctionNov 20, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DOCTOR WAS REPLACING THE CATHETER BECAUSE THE CURRENT CATHETER IN PLACE WAS TOO SHORT FOR THE PATIENT. WHEN THE PHYSICIAN REMOVED THE CATHETER HE NOTICED BLISTERING ON THE PART OF THE SILVER ION SLEEVE THAT WAS INSERTED INTO THE PATIENT¿S BODY. THE EXTERNAL PORTION OF THE CATHETER DID NOT HAVE ANY BLISTERING OR BUBBLING ON THE SILVER ION SLEEVE. THE DOCTOR REPORTED NO ISSUES WITH THE PATIENT BECAUSE OF THE BLISTERING. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7044963 ↗

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-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-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-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-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-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-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-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

…and 33 more.