Palindrome 8888145039Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521056657), received between Apr 5, 2019 and Dec 29, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K111372); 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-1316-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON (B)(6), 2022, THE PATIENT WAS IMPLANTED WITH LEFT FEMORAL VEIN CATHETER WITH DACRON SLEEVE (CENTRAL VENOUS CATHETER KIT) IN THE HOSPITAL FOR HEMODIALYSIS; THE INTERNAL ORIFICE DID NOT HEAL (THE WOUND AT THE PUNCTURE POINT COULD NOT HEAL). ON (B)(6) 2022, THE PATIENT WENT TO THE HOSPITAL TO SEEK A SOLUTION. AFTER COMPREHENSIVE CONSIDERATION, THE DIRECTOR'S TEAM DECIDED TO RE-IMPLANT THE CENTRAL VENOUS CATHETER KIT IN THE PATIENT'S RIGHT NECK. IT WAS STATED THAT FOR THIS SPECIAL CASE, THE DIRECTOR POINTED OUT THAT THIS WAS DUE TO INDIVIDUAL DIFFERENCES IN PATIENTS, AND THERE WAS REJECTION OF THE CATHETER, WHICH HAS NOTHING TO DO WITH THE QUALITY OF THE IMPLANTED CATHETER.

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

  MAUDE report 16075299 ↗
• MalfunctionNov 4, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE CATHETER WAS INSERTED ON (B)(6) 2022. PATIENT CAME FOR DIALYSIS ON (B)(6) 2022. DURING DISCONNECTION OF BLOODLINE FROM THE HUB WHEN TREATMENT WAS ALREADY COMPLETED, IT WAS FOUND THAT THE VENOUS (BLUE) LUER ADAPTER HAD A CRACK AND DROPPED OFF WHEN USER DISCONNECTED THE LINE (LUER ADAPTER DETACHED). THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THE ADAPTERS WERE TIGHTENED BY HAND. HEXODANE 2% WITH ALCOHOL WAS THE CLEANING AGENT USED ON THE DEVICE AND TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. FLUSHING WAS DONE AT THE END OF DIALYSIS AND RINSE BACK WAS DONE BY DIALYSIS MACHINE. FLUSHING HAD A NORMAL RESULTS AND IT WAS MENTIONED THAT THERE WAS NO MACHINE ALARMS. THE DOCTOR WAS INFORMED, CLAMP REMAINED CLOSED AND CATHETER LIMB WAS WRAPPED WITH STERILE GAUZE AND CATHETER EXCHANGE WAS DONE TO RESOLVE THE ISSUE. A NEW DEVICE WAS USED (CATHETER REPLACEMENT). THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15739416 ↗
• MalfunctionSep 30, 2022Break; Break

  ACCORDING TO THE REPORTER, AFTER COMPLETING THE CATHETER INSERTION AND BEFORE PUTTING THE CORK, A CRACK WAS OBSERVED ON THE BLUE LUER LOCK AND THE CATHETER WAS REMOVED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND FLUSHING WAS PERFORMED WITH SALINE WITH NO PROBLEM RESULT. THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, AND THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT (JUST THE CRACK THAT WAS DOCUMENTED). THE CATHETER WAS REPAIRED, THERE WAS NO LEAK, THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE, SALINE WAS USED AS THE CLEANING AGENT, AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO METHOD UTILIZED TO LOOSEN/TIGHTEN THE ADAPTER, THE CATHETER THAT CAME WITH THE KIT WAS THE ONE USED, AND THERE WAS NO EXCESSIVE FORCE USED ON THE CATHETER. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT, AND THERE WAS NO ANY INTERVENTION/TREATMENT REQUIRED AS THE RESULT OF THE EVENT. THE CATHETER WAS REPLACED WITH ANOTHER CATHETER (CUSTOMER DID NOT SPECIFY WHICH PRODUCT). THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15520651 ↗
• MalfunctionSep 3, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER WAS NOTED TO HAVE TWO PIN HOLES IN THE ARTERIAL LUMEN 5 DAYS POST INSERTION. FLUSHING WAS DONE AND LEAKAGE WAS NOTED WHEN PATIENT'S ACCESS WAS USED. LUMEN WAS NOT USED AND LEFT CLAMPED BELOW WHERE THE HOLES WERE IDENTIFIED UNTIL REPAIR COULD BE DONE. IT WAS REPORTED THAT REPAIR WAS DONE JULY 28, 2020. IT WAS ALSO MENTIONED THAT CLAMPS ARE ROUTINELY MOVED ALONG THE LENGTH OF THE EXTENSION. CHLORHEXIDINE 2% AND ALCOHOL 70% WAS USED TO CLEAN THE DEVICE, TEGO WAS UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS A BLOOD LOSS OF 1ML, BLOOD TRANSFUSION WAS NOT REQUIRED. THE TREATMENT WAS COMPLETED AFTER THE PRODUCT WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10486904 ↗
• MalfunctionAug 7, 2019Break; Material Integrity Problem; Break; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE PEEL-AWAY SHEATH (DILATOR) OF THE DEVICE WAS FOUND TO BE BENT AT THE TIP AS IT PASSES THROUGH THE SKIN'S ENTRANCE HOLE INTRAOPERATIVELY. IT WAS ALSO STATED THAT THERE WAS A CRACK OBSERVED IN THE LUER ADAPTER. IT WAS NOTED THAT THE CATHETER WAS NOT REPAIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8872470 ↗
• MalfunctionApr 5, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CATHETER WAS FOUND TO BE LEAKING FROM THE CLEAR TUBING ON THE BROWN LINE. THERE WERE TWO PINHOLES FOUND IN THE SILICONE TUBING AND FLUSHING WAS RECOMMENDED TO SEE THE HOLES. AS A RESULT, THE CATHETER WAS REMOVED AND ANOTHER CATHETER WAS INSERTED TO RESOLVE THE ISSUE. THERE WAS NO LEAKING AT THE JUNCTION OF THE BIFURCATE AND CATHETER, THERE WAS NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS TREATED WITH CHLOROPREP PRIOR TO PRODUCT PLACEMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8488281 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111372. One submission often covers many models, so check the product and lot details in each record.

• Z-2632-2023 · Aug 22, 2023 · Open, Classified
  Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
• Z-1320-2022 · Jun 8, 2022 · Open, Classified
  Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.