Palindrome 8888145057PRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521158276), received between Jul 18, 2018 and Jun 21, 2023 — classified as 1 death, 4 injuries, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, ONE OF THE VASCULAR SURGEONS IMPLANTED A PRECISION HIS (HEPARIN COATED & SILVER ION ANTIMICROBIAL) CHRONIC CATHETER KIT ON THE DAY OF THE EVENT. THE THUMB HANDLE PIECE (WHICH WAS USED WHEN PEELING AWAY THE SHEET) BROKE OFF AND COMPLETELY SEPARATED WHEN IT WAS ATTEMPTED TO BE PEELED AWAY. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS DONE PRIOR TO USE WITH NO PROBLEM. THERE WAS NO LEAK. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WERE NO RESISTANCE WHEN THE PULL APART SHEATH WAS BEING INSERTED. THERE WAS NO EXCESSIVE FORCE APPLIED ON THE DEVICE. THE CATHETER WAS ALREADY IN PLACE WHEN THE SHEATH BROKE APART. THE SHEATH PIECE FELL INTO THE PATIENT'S BODY. A HEMOSTAT WAS USED TO GRAB THE END OF THE SHEATH TO RETRIEVE THE PIECE FROM THE PATIENT, AND AN X-RAY MACHINE WAS USED TO MAKE SURE ALL THE PIECES OF THE SHEATH WERE RETRIEVED. ALL THE PIECES WERE RETRIEVED FROM THE PATIENT. THIS CREATED A CHALLENGE FOR THE SURGEON, BUT THE PEEL-AWAY PROCESS WAS SUCCESSFULLY COMPLETED. THIS WAS A PATIENT-SAFETY ISSUE AND LACK

  Patient problems: Unintended Radiation Exposure

  MAUDE report 17176440 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT DEVELOPED A CATHETER ASSOCIATED INFECTION. THE TYPE OF INFECTION THE PATIENT HAD WAS OSTEOMYELITIS, BACTEREMIA. PATIENT'S SYMPTOMS PRIOR TO INFECTION WERE FEVER, LEUKOCYTOSIS AND POSITIVE BLOOD CULTURES. IT WAS STATED THAT ON (B)(6) 2022 THE ISSUE WAS OBSERVED THROUGH ID (INFECTIOUS DISEASE) CONSULTATION. A RECALL ALERT WAS RECEIVED BY THE CUSTOMER ON (B)(6) 2022. THEY ALERT THE STATES THAT POTENTIAL LEAKING AT THE HUB HAD BEEN IDENTIFIED BY OUR SIDE. THE PATIENT WAS IDENTIFIED TO HAVE A CENTRAL LINE ASSOCIATED BLOOD STREAM INFECTION (CLABSI) ON THE DATE OF THE EVENT. THE PATIENT WAS TRANSFERRED TO LTAC (LONG TERM ACUTE CARE FACILITY) WITH PERMANENT HD LINE IN PLACE. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LUER ADAPTER ISSUE. TEGO WAS UTILIZED. ALCOHOL PAD WAS THE CLEANING AGENT USED ON THE DEVICE. CHLORAPREP (DURAPREP FOR IODINE ALLERGY) WAS THE CLEANING AGENT USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT AND FLUSHING WAS PERFORMED PRIOR TO USE. THE CATHETER WAS REPLACED WITH A NEW DEVICE (UNAFFECTED LOT) TO RESOL

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

  MAUDE report 15331864 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD INFECTION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Unspecified Infection

  MAUDE report 15269735 ↗
• 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. 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 TRANSFERRED TO LTAC (B)(6) 2022 WITH PERM HD LINE IN PLACE. FDA SAFETY REPORT ID #(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15198346 ↗
• DeathAug 8, 2022Contamination; Leak/Splash

  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. PERM HD CATHETER REMOVED (B)(6) 2022 AND TIP SENT FOR CULTURE. PATIENT THEN EXPIRED (B)(6) 2022. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 15192168 ↗
• MalfunctionJul 22, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING DIALYSIS, A PIN HOLE WAS NOTED AND AIR WAS DETECTED IN THE LINE BY THE DIALYSIS MACHINE. IT WAS STATED THAT THE PIN HOLE WAS LOCATED IN THE EXTENSION TUBING AT THE BASE OF THE BLUE (VENOUS LUMEN) ADAPTER AND LEAK WAS ALSO OBSERVED. THERE WAS NO CRACK OR LUER ADAPTER ISSUE. CATHETER WAS EXCHANGED AND A NEW ONE WAS SUCCESSFULLY INSERTED. CHLORAPREP WAS THE CLEANING AGENT USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT IN THE OPERATING ROOM AND THE SURGEON USED A BETADINE ON THE EXCHANGE. FLUSHING WAS DONE AND THE CATHETER FUNCTIONED PROPERLY WHEN ORIGINALLY INSERTED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE CATHETER WAS NOT REPAIRED AND NO TEGO UTILIZED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211010 ↗
• MalfunctionOct 13, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE NURSE NOTICED A PIN HOLE ON ARTERIAL EXTENSION AND A SMALL AMOUNT OF BLOOD WAS LEAKING WHEN CONNECTING TO PATIENT. CHLORHEXIDINE WAS THE CLEANING AGENT USED ON THE DEVICE. INSERTION WAS TREATED WITH PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO TEGO UTILIZED AND NO LUER ADAPTER ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10669874 ↗
• MalfunctionJul 18, 2018Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation

  ACCORDING TO THE REPORTER, THE STAFF REACHED OUT AND SAID THAT THEY RECEIVED A PATIENT BACK TO REMOVE THEIR CATHETER. THE CATHETER WAS FOR REMOVAL BECAUSE THE PATIENT NO LONGER NEEDED DIALYSIS. DURING REMOVAL OF THE CATHETER, THEY NOTICED BLISTERING ON THE SILVER ION SLEEVE AT THE EXIT SITE. THE CATHETER WAS REPLACED AND REMOVED BY THE PHYSICIAN. THE CATHETER WAS PLACED ON PATIENT'S INTERNAL JUGULAR VEIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7700434 ↗

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-1888-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision H 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-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-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-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-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-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-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

…and 33 more.