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Palindrome 8888119364PRecalls & reported problems

Mozarc Medical US LLC · Precision Chronic Catheter Sport Pack,Symmetrical Tip, Tal VenaTrac Stylet,14.5 Fr/Ch (4.8 mm) x 19 cm · Class 2 · Implant

All models of Palindrome (133)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
17
Deaths reported
1
Injuries reported
3
Recalls naming it
2

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521157705), received between Sep 27, 2018 and Aug 23, 2024 — classified as 1 death, 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (5 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 3 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Apr 23, 2025Class IIOpen, Classified

    Potential breach of sterile barrier packaging.

    Z-1885-2025 · 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-1312-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

  • Material Puncture/Hole5
  • Break4
  • Infusion or Flow Problem2
  • Material Fragmentation2
  • Defective Component1
  • Detachment of Device or Device Component1
  • Fluid/Blood Leak1
  • Misconnection1

Patient problems

  • No Clinical Signs, Symptoms or Conditions7
  • No Consequences Or Impact To Patient7
  • Endocarditis1
  • Failure of Implant1
  • Heart Block1
  • Insufficient Information1
  • No Code Available1
  • No Information1

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 23, 2024Break; Break

    ACCORDING TO THE REPORTER, DURING NORMAL USE, THE CATHETER HAD LEAKAGE AND A CRACKED HUB. IT WAS STATED THAT THE CATHETER HAD BEEN REPAIRED NUMEROUS TIMES. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20057312 ↗
  • MalfunctionAug 23, 2024Protective Measures Problem; Protective Measures Problem

    ACCORDING TO THE REPORTER, DURING NORMAL USE, THE CATHETER HAD LEAKAGE AND A CRACKED HUB. IT WAS STATED THAT THE CATHETER HAD BEEN REPAIRED NUMEROUS TIMES. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT OUTCOME.

    Patient problems: Insufficient Information

    MAUDE report 20049382 ↗
  • MalfunctionAug 9, 2024Material Fragmentation; Material Fragmentation

    ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CATHETER THAT WAS USED IN A CASE WAS DEEMED DEFECTIVE. THE TUNNELER COLLAPSED ON ITSELF WHEN IT WAS USED ON THE PATIENT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19951209 ↗
  • MalfunctionSep 15, 2023Material Fragmentation; Material Fragmentation

    ACCORDING TO THE REPORTER, WHILE INSERTING THE CATHETER AND SHEATH BEING PULLED APART, THE PULL APART SHEATH HANDLES JUST SIMPLY BROKE OFF LEAVING THE TUBE PORTION IN THE PATIENT'S NECK. THERE WAS JUST AN ISSUE CONTINUING WITH THE PROCEDURE AS THE PULL APART SHEATH WAS ALREADY IN MOTION OF PULLING APART WITH ENTRY OF CATHETER WHICH MADE IT DIFFICULT TO CONTINUE TO INSERT THE CATHETER. AGAIN, THE ISSUE WAS THE WINGS OR HANDLES OF THE PULL APART SHEATH BROKE OFF WHILE INSERTING THE CATHETER DOWN THE INNER LUMEN. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE PULL APART SHEATH WAS THE ONE INCLUDED IN THE CATHETER KIT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND NO DAMAGES WERE FOUND ON PULL APART SHEATH. THERE WERE NO OTHER PRODUCTS UTILIZED ASIDE FROM THE PRODUCTS INSIDE THE CATHETER SPORT PACK. THE CATHETER WAS FLUSHED WITH NORMAL RESULT BUT INFORMATION WAS NOT PROVIDED OF FLUSHING THE PULL APART SHEATH. THEY WERE ABLE TO PUSH THE CATHETER DOWN AND ABLE TO COMPLETE THE PULL APART SHEATH TO RESOLVE THE ISSUE. THE SHEATH WAS NOT REPLACED WITH A NEW

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17761448 ↗
  • InjuryDec 28, 2022Material Puncture/Hole; Material Puncture/Hole

    ACCORDING TO THE REPORTER, DURING DIALYSIS RUN, AIR WAS PULLED INTO THE CATHETER THROUGH A SMALL HOLE IN THE RED ARTERIAL EXTENSION TUBE (RED LUMEN) OF THE CATHETER UNDER WHERE THE CLAMP SITS IN THE MIDDLE OF THE SOFT CLEAR PART OF THE TUBING, CREATING BUBBLES IN THE DIALYSIS CIRCUIT AND RED EXTENSION TUBE. THE PATIENT DID NOT FINISH THE DIALYSIS TREATMENT, THE NURSES COVERED THE CATHETER LIMBS AND HUB WITH OCCLUSIVE TEGADERM DRESSINGS TO PREVENT FURTHER AIR BEING INTRODUCED AND THIS ALSO CAUSED THE PATIENT TO BE BROUGHT URGENTLY TO A HOSPITAL 4 HOURS AWAY (PATIENT HAVE TO COME FROM TRAIL TO (B)(6)) TO HAVE THE PATIENT ADMITTED AND HAVE THE REPORTED CATHETER REMOVED AND IMMEDIATELY REPLACED. THE CATHETER HAD BEEN IN PLACE FOR ONE WEEK AT THE TIME OF THE EVENT. THERE WAS JUST ONE HOLE NOTED ON THE REPORTED PRODUCT (HOLE IN THE RED EXTENSION TUBE). THERE WAS NO LEAK AT THE JUNCTION OF THE BIFURCATE AND CATHETER AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVE ON THE DEVICE PRIOR TO USE BECAUSE OTHERWISE IT WOULD NOT BE IMPLANTED, BESIDES THE HOLE THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THERE WERE OTHER PRODUCTS UTILI

    Patient problems: Failure of Implant

    MAUDE report 16064249 ↗
  • DeathJul 7, 2022Separation Problem; Separation Problem

    ACCORDING TO THE REPORTER, THE PATIENT PASSED AWAY AND DURING PREPARATION OF THE BODY THE VASCULAR CATHETER WAS REMOVED AND WAS NOTED TO BE MISSING THE TIP, WHICH HAD BROKEN OFF. IT WAS REPORTED THAT IT WAS UNLIKELY THAT THE TIP DETACHMENT WAS RELATED TO THE PATIENT'S DEATH AS THEY DIED FROM SHOCK, COMPLETE HEART BLOCK AND MITRAL VALVE ENDOCARDITIS WHICH ALL EXPLAIN THEIR DECOMPENSATION AND PASSING. THE TIP DETACHMENT MAY HAVE OCCURRED DURING CHEST COMPRESSIONS WHICH WERE PERFORMED DURING THE PATIENT'S CARDIAC ARREST.

    Patient problems: Endocarditis; Heart Block; Shock

    MAUDE report 14947092 ↗
  • MalfunctionMay 14, 2021Material Puncture/Hole; Material Puncture/Hole

    ACCORDING TO THE REPORTER, THE CATHETER WAS PLACED IN PATIENT AND FLUSHED WITHOUT ISSUES. THE PATIENT WENT TO DIALYSIS FOR (HEMODIALYSIS) HD TREATMENT AND THE CATHETER BEGAN TO LEAK FROM THE VENOUS EXTENSION TUBING UNDERNEATH THE CLAMP. A NEW CATHETER OF THE SAME TYPE WAS PLACED. THE NEW CATHETER WAS USED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED. NOTHING UNUSUAL OBSERVED PRIOR TO USE. THE CATHETER WAS NOT REPAIRED, AND THERE WAS NO LUER ADAPTER ISSUE. NO OTHER INTERVENTION/TREATMENT REQUIRED. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11824594 ↗
  • MalfunctionMay 10, 2021Defective Component; Infusion or Flow Problem; Defective Component; Infusion or Flow Problem

    ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE PHYSICIAN INJECTED CONTRAST/SALINE SOLUTION THROUGH EXISTING TUNNELED HD (HEMODIALYSIS) CATHETER AND FIBRIN SHEATH WAS FOUND. THEY USED A 10CC SYRINGE BY HAND TO INFLATE THE BALLOON FOR FIBRIN SHEATH DISRUPTION. THE BALLOON WAS SUCCESSFULLY INFLATED THE FIRST TIME AND REMOVED WITH NO ISSUES. THEY TRIED TO INSERT STYLETS THROUGH THE VENOUS (BLUE) LUMEN OF THE CATHETER BUT IT HIT RESISTANCE AND IT WOULD NOT GO/ADVANCE INTO THE LUMEN CAUSING THE STYLET TO KINK. THERE WAS A PROBLEM WITH THE CATHETER'S DIAMETER THAT SEEMED TO BE SMALLER ON THE VENOUS LUMEN. THEY WERE ABLE TO INSERT THE STYLET THROUGH THE ARTERIAL (RED) LUMEN. THEY TRIED TO INSERT THE CATHETER OVER GUIDEWIRE WITH STYLET ONLY IN RED LUMEN. AFTER INSERTION, THE PHYSICIAN WAS CHECKING THE CATHETER AND EXPERIENCED RESISTANCE WHEN PUSHING PULLING BLOOD THROUGH THE VENOUS (BLUE) LUMEN (NOT THE INFUSION LINE). IT WOULD NOT FLUSH AND REMOVE CLOTS. THE LINE WAS NOT HARD TO FLUSH WHEN FLUSHING WITH SALINE. THERE WAS NO ANTI COAGULATION USED. THERE WAS BLOOD RETURN PRIOR TO SYRINGE FLUSH. THEY DID NOT REVERSE THE LINES. THEY REMOVED THE CATHETER AND REINSERTED THE BALLOON TO INFLATE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11797975 ↗
  • MalfunctionApr 2, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

    ACCORDING TO THE REPORTER, THE VENOUS PORT LINE OF THE CVC (CENTRAL VENOUS CATHETER) HAD A BLOOD LEAK AND CRACK/SLICE WAS NOTED. IT WAS ALSO STATED THAT LINE EXCHANGE WAS DONE, THE CATHETER WAS NOT REPAIRED, POVIDONE IODINE WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT AND AS THE CLEANING AGENT ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. IT WAS ALSO STATED THAT TEGO WAS UTILIZED, THE TREATMENT WAS PROCEEDED AFTER THE LINE WAS REPLACED AND AS THE INTERVENTION DONE. THERE WAS A SMALL AMOUNT OF BLOOD LOSS, BLOOD TRANSFUSION WAS NOT REQUIRED, BLOOD OR SALINE HAD A LEAK AFTER IT WAS FLUSHED, THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE, THE BLOOD OF THE PATIENT WAS SAFELY RETURNED, CHG (GLUCONATE AND CHLORHEXIDINE) WAS TYPICAL USED TO CLEAN THE ADAPTERS, AND NO OINTMENT WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11607680 ↗
  • MalfunctionNov 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, WHEN THE PATIENT WAS CONNECTED TO THE MACHINE FOR HEMODIALYSIS, THE NURSE HAD DIFFICULTY TO DRAW AND FLUSHED THE VENOUS (BLUE) LINE OF THE CATHETER. LINE WAS FLUSHED WITH NORMAL SALINE AND RECONNECTED TO THE MACHINE WITH ARTERIAL MACHINE LINE CONNECTED TO THE PATIENT¿S VENOUS CATHETER LINE AND VENOUS MACHINE LINE TO THE PATIENT¿S ARTERIAL LINE. AFTER ANOTHER FLUSHING, THE VENOUS LIMB AND COLORED END OF THE CATHETER BROKE OFF AND SPLIT INTO TWO. IT WAS STATED THAT THE CATHETER WAS REPLACED AND THE PATIENT HAD A MEDICAL CARE. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO PATIENT INJURY.

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

    MAUDE report 10834311 ↗
  • MalfunctionJul 2, 2020Obstruction of Flow; Obstruction of Flow

    ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE STYLET COULD NOT PASS THROUGH THE CATHETER LUMEN (WAS PARTIALLY OCCLUDED). THEY TRIED IT SEVERAL TIMES (TRIED BOTH STYLETS IN EACH LUMEN) BUT IT WOULD NOT PASS THROUGH THE LUMEN. THEY COULD NOT IMPLANT THE CATHETER. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO DAMAGE NOTED ON THE KIT'S PACKAGING AND BOX OF THE CATHETER AND THE PACKAGE WAS STILL SEALED UPON RECEIPT. THE DIMENSIONS ON THE CATHETER MATCH THE MEASUREMENTS ON THE BOX. THEY HAD TO OPEN A DIFFERENT CATHETER TO RESOLVE THE ISSUE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10227368 ↗
  • InjuryJan 28, 2020Material Puncture/Hole; Material Puncture/Hole

    ACCORDING TO THE REPORTER, NEAR THE END OF DIALYSIS TREATMENT, THERE WAS A HOLE AND LEAKAGE FOUND ON THE ARTERIAL SIDE OF THE DEVICE (MIDDLE OF THE TUBE/DISTAL TO WHITE CLAMP). THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT USED, AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. REPEATED CLAMPING WAS NOT PERFORMED PRIOR TO USE. THE OTHER PRODUCTS UTILIZED WERE DEXIDIN 2 SOLUTION, 4X4 GAUZE, AND TEGRDERM DRESSING. THERE WAS AN EVENTUAL BLOOD LOSS OF 5 ML ON THE LINE AND PATIENT'S GOWN AND APPROXIMATELY 300 ML IN THE HEMODIALYSIS LINES AS BLOOD WAS NOT RETURNED. BLOOD TRANSFUSION WAS NOT REQUIRED. THE CATHETER WAS REMOVED AND REPLACED IN ORDER TO RESOLVE THE ISSUE. ANTIBIOTIC COURSE OF CEFAZOLIN ONE GRAM WAS GIVEN TO THE PATIENT INTRAVENOUSLY AS A PROTOCOL FOR CONTAMINATION. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Code Available; No Consequences Or Impact To Patient

    MAUDE report 9638468 ↗
  • MalfunctionDec 10, 2019Material Puncture/Hole; Material Puncture/Hole

    ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THERE WAS LEAKAGE AS THERE WAS FOUND TO BE A PINHOLE IN THE SILICONE EXTENSION OF THE VENOUS LUMEN UNDER THE CLAMP. THIS WAS EVIDENT AS THE CATHETER WAS UNDER HIGHER PRESSURE FROM THE DIALYZER. IT WAS STATED THAT THE PINHOLE WAS NOT NOTICED DURING CATHETER INSERTION AFTER FLUSHING WAS DONE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. THE DEVICE WAS REPLACED IN ORDER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9442859 ↗
  • MalfunctionJun 4, 2019Infusion or Flow Problem; Infusion or Flow Problem

    ACCORDING TO THE REPORTER, DURING USE, WHEN THEY ARE ASSESSING THE CATHETER FOR DIALYSIS INITIATION, AN UNUSUAL SOUND WAS NOTED WHEN INSTILLING OR FLUSHING THE DEVICE WITH STERILE NORMAL SALINE. A DECISION WAS MADE TO NOT PROCEED WITH DIALYSIS AT THAT TIME. IT WAS STATED THAT LOCAL PROCEDURE GUIDELINE FOR ACCESSING A CATHETER FOR INITIATION OF DIALYSIS INCLUDES: CLEANSING EACH LUMEN AND LIMB WITH APPROVED CLEANSING SOLUTION (WE STOCK 2% CHLORHEXIDINE + 70% ALCOHOL, 2% W/V CHLORHEXIDINE GLUCONATE, AND 10% W/W POVIDONE-IODINE); WITHDRAWING THE 4% SODIUM CITRATE SOLUTION USED TO LOCK THE CATHETER FROM EACH LUMEN; THEN FLUSH EACH LUMEN WITH 20ML NORMAL SALINE USING A ¿PUSH/PAUSE¿ METHOD. ON THE DATE OF EVENT, THE RN (REGISTERED NURSE) WAS UNABLE TO ASPIRATE FROM THE ARTERIAL LUMEN ¿ THE ARTERIAL LUMEN WAS REPORTEDLY SLOW TO FLUSH, OR FLUSHED WITH SOME RESISTANCE, AND THE UNUSUAL ¿SWOOSH¿ SOUND WAS NOTED WITH THE ARTERIAL LUMEN FLUSHING. THE VENOUS LUMEN WITHDREW AND FLUSHED NORMALLY, AND NO ¿SWOOSH¿ SOUNDS WAS NOTED. IT WAS ALSO REPORTED THAT T HE PATIENT HAD BEEN ON A HEPARIN INFUSION FROM THE DATE DEVICE WAS IMPLANTED BUT WAS NOT STATED WHEN THIS WAS DISCONTINUED. PRIOR TO THE EVENT,

    Patient problems: No Consequences Or Impact To Patient; No Information

    MAUDE report 8666588 ↗
  • InjuryMay 27, 2019Break; Misconnection; Break; Misconnection

    ACCORDING TO THE REPORTER, DURING USE, THEY SUSPECTED A PINHOLE IN THE CATHETER, ALTHOUGH THEY WERE UNABLE TO IDENTIFY WHERE AIR WAS DRAWN INTO THE SYSTEM UPON PATIENT CONNECTION. IT WAS STATED THAT LUER LOCK AND SLIP TIP SYRINGES DID NOT FIT TIGHTLY, ALTHOUGH THREADS LOOK OKAY. CATHETER BECAME INFECTED AND WAS REMOVED. IT WAS ALSO STATED THAT PINHOLE WAS PREVIOUSLY NOTED BEFORE BECOMING INFECTED AND REMOVED. THERE WAS NO REPORTED PATIENT OUTCOME.

    Patient problems: Unspecified Infection

    MAUDE report 8644383 ↗
  • MalfunctionFeb 3, 2019Break; Break

    ACCORDING TO THE REPORTER, DURING HD (HEMODIALYSIS) TREATMENT, THE CATHETER CRACKED. IT WAS STATED THAT A CRACK OF LESS THAN 2MM WAS NOTED IN THE LUMEN BETWEEN THE HUB AND THE PORTS (CLEAR PART UNDER THE CLAMPS) AND CAUSED LEAKS OF BLOOD DURING FLUSHING. IN ORDER TO RESOLVE THE ISSUE, A NEW CATHETER WAS USED. IT WAS ALSO STATED THAT CHLORHEXADINE WITH ALCOHOL SWABS WAS THE CLEANING SOLUTION USED ON THE CATHETER AND NO OINTMENT WAS USED. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8300593 ↗
  • MalfunctionSep 27, 2018Break; Break

    ACCORDING TO THE REPORTER, THE CATHETER WAS DEFECTIVE, IT HAD A SMALL HOLE JUST AS ITS EXIT SKIN. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7914692 ↗

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-1886-2025 · Apr 23, 2025 · Open, Classified
    Palindrome Precision HSI 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-1315-2022 · Jun 8, 2022 · Open, Classified
    Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. 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-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-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-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-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-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.

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