Palindrome 8888119369PRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521157736), received between May 2, 2018 and Aug 29, 2022 — classified as 1 death, 13 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (7 reports).

3 FDA recall records name this device's identifier, 3 still open.

46 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. Mar 15, 2024Class IIOpen, Classified

   Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating

   Z-1634-2024 · Root cause: Process control · Recall details · FDA record ↗

3. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 AND A PERM HEMODIALYSIS (HD) CATHETER WAS INSERTED. ON (B)(6) 2022, IT WAS SAID THAT THERE WAS A SEAL ALERT RECEIVED REGARDING RECALL OF AFFECTED CATHETERS FROM OUR COMPANY. THE ALERT STATED THAT OUR COMPANY HAS IDENTIFIED POTENTIAL LEAKING AT THE HUB AND RECALLED THE AFFECTED DEVICES. THE CATHETER WAS ALREADY INSERTED TO THE PATIENT (INTERNAL JUGULAR VESSEL, TERMINATED OUT THE CHEST) BEFORE THE ALERT WAS RECEIVED ON (B)(6). FLUSHING WAS PERFORMED PRIOR TO INSERTION AND NO ABNORMALITIES NOTED OR REPORTED (NORMAL), NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WERE NO DEFECTS/DAMAGES FOUND ON THE PRODUCT. ON (B)(6) 2022, THE PATIENT WAS IDENTIFIED TO HAVE A CENTRAL LINE ASSOCIATED BLOODSTREAM INFECTION (CLABSI) AND WAS MENTIONED THAT IT WAS A DRUG RESISTANT BACTERIAL INFECTION. IT WAS STATED THAT THE TYPE OF INFECTION THE PATIENT HAD WAS BACTEREMIA (BLOOD INFECTION). ALCOHOL PAD WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. CLEAR GUARD AND TEGOS WERE BEING UTILIZED WITH THE DEVICE. THE INSERTION SITE WAS TREATED WITH CHLORAPREP (DURAPREP FOR IODINE ALLERGY) PRIOR TO PRODUCT PLACEMENT. THER

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Atrial Fibrillation; Bacterial Infection; Drug Resistant Bacterial Infection; Low Blood Pressure/ Hypotension

  MAUDE report 15312401 ↗
• MalfunctionJun 16, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER'S BLUE (VENOUS) LUER ADAPTER HAD A HAIRLINE CRACK AND A LEAK. THE CATHETER WAS NOT REPAIRED AND TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED WITH CHLORAPREP PRIOR TO PRODUCT REPLACEMENT. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14717275 ↗
• MalfunctionApr 4, 2019Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  ACCORDING TO THE REPORTER, DURING USE, THE CENTRAL VENOUS CATHETER'S CUFF WAS SMALLER THAN THE USUAL SIZE WHICH MADE IT EASY TO MIGRATE WITH THE CUFF EXPOSED EVEN THOUGH THE CATHETER HAS BEEN IN THE PATIENT FOR MORE THAN SIX MONTHS. THE REASON FOR THE CENTRAL VENOUS CATHETER TO BE EXCHANGED WAS "MIGRATION OF CVC WITH CUFF EXPOSED." THE PART OF THE CATHETER THAT WAS COATED FORMED SMALL AIR POCKETS/SMALL BLISTERS RIGHT NEXT TO THE CUFF WHICH WAS IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483588 ↗
• 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. A CUSTOMER REPORTED SUTURES HAD BEEN REMOVED AS NORMAL PROTOCOL. AND IT WAS INDICATED THAT THERE WERE ALSO BUBBLES ON THE SILVER ION SLEEVE BUT NO SIGNS OF INFECTION. A COMPETITOR'S CATHETER WAS INSERTED TO RESOLVE THE ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952960 ↗
• MalfunctionOct 3, 2018Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  ACCORDING TO THE REPORTER, DURING USE AT HOME SOON AFTER THE SCHEDULED SUTURE REMOVAL OF THE PATIENT, THE CATHETER WAS COMPLETELY DETACHED FROM THE PATIENT'S BODY AND FELL OUT BUT NO INCIDENT OF BLOOD LOSS OCCURRED. THE CATHETER WAS IMPLANTED ON PATIENT'S LEFT INTERNAL JUGULAR VEIN AND IT HAS BEEN IN USE FOR A VERY SMALL PERIOD OF TIME OR MONTHS. IT WAS ALSO REPORTED THAT BUBBLING ON THE SILVER ION SLEEVE OF THE DEVICE WAS NOTED. THE PATIENT HAD TO HAVE A NEW CATHETER INSERTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7929556 ↗
• MalfunctionOct 3, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER WAS COMPLETELY DETACHED FROM THE PATIENT'S BODY AND FELL OUT ONE DAY AFTER THE SCHEDULED SUTURE REMOVAL. A NEW CATHETER HAD TO BE INSERTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7929527 ↗
• MalfunctionAug 31, 2018Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE SECOND DEVICE FELL OUT FROM THE PATIENT. IT WAS REPORTED THE SECUREMENT WING WAS SUTURED. AND THERE WERE NODULES ON THE SILVER ION SLEEVE. IT WAS REPORTED THE CATHETER WAS REMOVED AND ANOTHER ONE WAS INSERTED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7838743 ↗
• MalfunctionAug 24, 2018Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE CATHETER FELL OUT AND THERE WERE BUBBLES ON THE HEPARIN SLEEVE. CUSTOMER REPORTED THE CATHETER WAS NOT SECURED. CATHETER WAS REMOVED AND ANOTHER ONE WAS INSERTED. IT WAS REPORTED THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7813086 ↗
• MalfunctionAug 20, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ACCORDING TO THE REPORTER, DURING TREATMENT, THE DEVICE FELL OUT. IT WAS REPORTED THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7798607 ↗
• 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 7583312 ↗
• 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 7582955 ↗
• 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 7582934 ↗
• 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 7582858 ↗
• MalfunctionMay 2, 2018Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, PRIOR TO THE DIALYSIS TREATMENT, THE CATHETER CUFF WAS EXPOSED, AND AFTER THE TREATMENT, THE CATHETER WAS EXPOSED FOR ANOTHER 6CM. THE PATIENT MENTIONED THAT HER (B)(6) CHILD HAD PULLED ON HER CATHETER A DAY PRIOR TO HER GOING FOR HER DIALYSIS TREATMENT. IT WAS STATED THAT THE CATHETER WAS REMOVED BY THE STAFF, AND UPON REMOVAL, IT WAS NOTICED THAT THERE WERE RAISED LESIONS ON THE OUTER SURFACE OF THE DIALYSIS CATHETER. IT HAD BEEN NOTED THAT THE PATIENT'S SKIN SEEMED SWOLLEN ALONG THE TRACK OF THE CATHETER, BUT NO SIGNS OF INFECTION WERE PRESENT. THE PATIENT'S SKIN WAS BEING CLEANSED WITH 2% CHG SWABSTICK OR BETADINE SWABSTICK. A NEW CATHETER WAS PLACED LAST (B)(6) 2018, AND DIALYSIS WAS BEING DONE ON A REGULAR SCHEDULED DAY WITH NO FURTHER COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7479337 ↗

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-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-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-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-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-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-0332-2016 · 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: 8888145046C The Palindrome chronic catheter is intended for
• Z-0333-2016 · Oct 14, 2015 · Terminated
  Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic cat

…and 31 more.