PalindromeRecalls & reported problems across all models
Mozarc Medical US LLC · 133 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
15 open recalls name at least one Palindrome model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,285
- Deaths reported
- 20
- Injuries reported
- 137
- Recalls
- 15
We found 133 models of Palindrome by Mozarc Medical US LLC in the FDA's device registry (GUDID). Together they are named in 1,285 adverse event reports in the FDA's MAUDE database, received between Sep 23, 2016 and May 26, 2026 — classified as 20 deaths, 137 injuries, 1,128 malfunctions.
The most frequently reported specific device problem is “Break” (508 reports).
15 FDA recall records name at least one of these models by its device identifier, 15 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Palindrome recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 23, 2025Open, Classified
Potential breach of sterile barrier packaging.
Z-1888-2025 · Root cause: Packaging · names 7 of these models · Recall details · FDA record ↗
- Apr 23, 2025Open, Classified
Potential breach of sterile barrier packaging.
Z-1887-2025 · Root cause: Packaging · names 4 of these models · Recall details · FDA record ↗
- Apr 23, 2025Open, Classified
Potential breach of sterile barrier packaging.
Z-1886-2025 · Root cause: Packaging · names 4 of these models · Recall details · FDA record ↗
- Apr 23, 2025Open, Classified
Potential breach of sterile barrier packaging.
Z-1885-2025 · Root cause: Packaging · names 12 of these models · Recall details · FDA record ↗
- Mar 15, 2024Open, 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-1635-2024 · Root cause: Process control · Recall details · FDA record ↗
- Mar 15, 2024Open, 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 ↗
- Aug 22, 2023Open, Classified
Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body.
Z-2632-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 8, 2022Open, 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-1319-2022 · Root cause: Process control · names 12 of these models · Recall details · FDA record ↗
- Jun 8, 2022Open, 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-1318-2022 · Root cause: Process control · names 9 of these models · Recall details · FDA record ↗
- Jun 8, 2022Open, 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-1317-2022 · Root cause: Process control · names 13 of these models · Recall details · FDA record ↗
- Jun 8, 2022Open, 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 · names 20 of these models · Recall details · FDA record ↗
- Jun 8, 2022Open, 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 · names 11 of these models · Recall details · FDA record ↗
- Jun 8, 2022Open, 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-1314-2022 · Root cause: Process control · names 9 of these models · Recall details · FDA record ↗
- Jun 8, 2022Open, 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-1313-2022 · Root cause: Process control · names 19 of these models · Recall details · FDA record ↗
- Jun 8, 2022Open, 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 · names 28 of these models · Recall details · FDA record ↗
Most reported Palindrome problems
Device problems
- Break508
- Material Puncture/Hole238
- Insufficient Flow or Under Infusion93
- Defective Component84
- Fluid/Blood Leak84
- Material Integrity Problem59
- Detachment of Device or Device Component56
- Product Quality Problem54
Patient problems
- No Clinical Signs, Symptoms or Conditions738
- No Consequences Or Impact To Patient278
- Insufficient Information175
- No Information42
- Unspecified Infection34
- Unintended Radiation Exposure31
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available26
- Bacterial Infection13
Palindrome models
133 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Palindrome 8888145014Catheter, hemodialysis, implanted1 recall312 reports
- Palindrome 8888145015Catheter, hemodialysis, implanted2 recalls1 death219 reports
- Palindrome 8888119369PCatheter, hemodialysis, implanted3 recalls1 death14 reports
- Palindrome 8888145044CPCatheter, hemodialysis, implanted, coated2 recalls2 deaths30 reports
- Palindrome 8888119364PCatheter, hemodialysis, implanted2 recalls1 death17 reports
- Palindrome 8888123404PCatheter, hemodialysis, implanted2 recalls1 death17 reports
- Palindrome 8888123409PCatheter, hemodialysis, implanted2 recalls1 death12 reports
- Palindrome 8888145014PCatheter, hemodialysis, implanted1 recall62 reports
- Palindrome 8888123410PCatheter, hemodialysis, implanted2 recalls9 reports
- Palindrome 8888145040PCatheter, hemodialysis, implanted1 recall1 death58 reports
- Palindrome 8888123400PCatheter, hemodialysis, implanted2 recalls5 reports
- Palindrome 8888128454PCatheter, hemodialysis, implanted2 recalls5 reports
- Palindrome 8888133504PCatheter, hemodialysis, implanted2 recalls3 reports
- Palindrome 8888119365PCatheter, hemodialysis, implanted, coated2 recalls2 reports
- Palindrome 8888123405PCatheter, hemodialysis, implanted, coated2 recalls2 reports
- Palindrome 8888119370PCatheter, hemodialysis, implanted2 recalls1 report
- Palindrome 8888128459PCatheter, hemodialysis, implanted2 recalls1 report
- Palindrome 8888133505PCatheter, hemodialysis, implanted, coated2 recalls1 report
- Palindrome 8888119368Catheter, hemodialysis, implanted2 recalls0 reports
- Palindrome 8888123408Catheter, hemodialysis, implanted2 recalls0 reports
- Palindrome 8888128458Catheter, hemodialysis, implanted2 recalls0 reports
- Palindrome 8888133508Catheter, hemodialysis, implanted2 recalls0 reports
- Palindrome 8888145062Catheter, hemodialysis, implanted2 recalls0 reports
- Palindrome 8888145063Catheter, hemodialysis, implanted2 recalls0 reports
- Palindrome 8888145064Catheter, hemodialysis, implanted2 recalls0 reports
- Palindrome 8888145065Catheter, hemodialysis, implanted2 recalls0 reports
- Palindrome 8888145066Catheter, hemodialysis, implanted2 recalls0 reports
- Palindrome 8888119360PCatheter, hemodialysis, implanted2 recalls0 reports
- Palindrome 8888123411PCatheter, hemodialysis, implanted, coated2 recalls0 reports
- Palindrome 8888128450PCatheter, hemodialysis, implanted2 recalls0 reports
- Palindrome 8888128455PCatheter, hemodialysis, implanted, coated2 recalls0 reports
- Palindrome 8888128460PCatheter, hemodialysis, implanted2 recalls0 reports
- Palindrome 8888128461PCatheter, hemodialysis, implanted, coated2 recalls0 reports
- Palindrome 8888133500PCatheter, hemodialysis, implanted2 recalls0 reports
- Palindrome 8888133509PCatheter, hemodialysis, implanted2 recalls0 reports
- Palindrome 8888133510PCatheter, hemodialysis, implanted2 recalls0 reports
- Palindrome 8888119371PCatheter, hemodialysis, implanted, coated2 recalls0 reports
- Palindrome 8888145043Catheter, hemodialysis, implanted1 recall45 reports
- Palindrome 8888145015PCatheter, hemodialysis, implanted1 recall1 death39 reports
- Palindrome 8888145016Catheter, hemodialysis, implanted1 recall1 death38 reports
- Palindrome 8888145044CCatheter, hemodialysis, implanted1 recall1 death38 reports
- Palindrome 8888145041PCatheter, hemodialysis, implanted1 recall33 reports
- Palindrome 8888145039PCatheter, hemodialysis, implanted1 recall31 reports
- Palindrome 8888145044Catheter, hemodialysis, implanted1 recall23 reports
- Palindrome 8888145017Catheter, hemodialysis, implanted1 recall22 reports
- Palindrome 8888145058Catheter, hemodialysis, implanted1 recall15 reports
- Palindrome 8888145018Catheter, hemodialysis, implanted1 recall12 reports
- Palindrome 8888145040Catheter, hemodialysis, implanted1 recall1 death12 reports
- Palindrome 8888145016PCatheter, hemodialysis, implanted1 recall1 death11 reports
- Palindrome 8888145048Catheter, hemodialysis, implanted1 recall10 reports
- Palindrome 8888145057Catheter, hemodialysis, implanted1 recall8 reports
- Palindrome 8888145017PCatheter, hemodialysis, implanted1 recall8 reports
- Palindrome 8888145044PCatheter, hemodialysis, implanted, coated1 recall8 reports
- Palindrome 8888145048PCatheter, hemodialysis, implanted1 recall3 deaths8 reports
- Palindrome 8888145057PCatheter, hemodialysis, implanted1 recall1 death8 reports
- Palindrome 8888145048CPCatheter, hemodialysis, implanted1 recall1 death7 reports
- Palindrome 8888145039Catheter, hemodialysis, implanted1 recall6 reports
- Palindrome 8888145043CPCatheter, hemodialysis, implanted, coated1 recall5 reports
- Palindrome 8888145042PCatheter, hemodialysis, implanted1 recall4 reports
- Palindrome 8888145045Catheter, hemodialysis, implanted1 recall3 reports
- Palindrome 8888145041Catheter, hemodialysis, implanted1 recall3 reports
- Palindrome 8888145057CCatheter, hemodialysis, implanted1 recall3 reports
- Palindrome 8888145049PCatheter, hemodialysis, implanted1 recall3 reports
- Palindrome 8888146044PCatheter, hemodialysis, implanted1 recall3 reports
- Palindrome 8888145059Catheter, hemodialysis, implanted1 recall2 reports
- Palindrome 8888145049Catheter, hemodialysis, implanted1 recall2 reports
- Palindrome 8888145045CCatheter, hemodialysis, implanted1 recall2 reports
- Palindrome 8888145048CCatheter, hemodialysis, implanted1 recall2 reports
- Palindrome 8888145045CPCatheter, hemodialysis, implanted, coated1 recall2 reports
- Palindrome 8888145046CPCatheter, hemodialysis, implanted, coated1 recall2 reports
- Palindrome 8888145049CPCatheter, hemodialysis, implanted1 recall1 death2 reports
- Palindrome 8888145058PCatheter, hemodialysis, implanted1 recall2 reports
- Palindrome 8888119360Catheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888119365Catheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888123409Catheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888145046Catheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888145060Catheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888145043CCatheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888123404Catheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888145042Catheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888145069Catheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888145049CCatheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888119368PCatheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888123408PCatheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888145018PCatheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888145043PCatheter, hemodialysis, implanted, coated1 recall1 report
- Palindrome 8888145045PCatheter, hemodialysis, implanted, coated1 recall1 report
- Palindrome 8888145046PCatheter, hemodialysis, implanted, coated1 recall1 report
- Palindrome 8888145059PCatheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888145060PCatheter, hemodialysis, implanted1 recall1 report
- Palindrome 8888119369Catheter, hemodialysis, implanted1 recall0 reports
- Palindrome 8888123400Catheter, hemodialysis, implanted1 recall0 reports
- Palindrome 8888123405Catheter, hemodialysis, implanted1 recall0 reports
- Palindrome 8888123410Catheter, hemodialysis, implanted1 recall0 reports
- Palindrome 8888128450Catheter, hemodialysis, implanted1 recall0 reports
- Palindrome 8888128459Catheter, hemodialysis, implanted1 recall0 reports
- Palindrome 8888128460Catheter, hemodialysis, implanted1 recall0 reports
- Palindrome 8888133500Catheter, hemodialysis, implanted1 recall0 reports
- Palindrome 8888133509Catheter, hemodialysis, implanted1 recall0 reports
- Palindrome 8888145050Catheter, hemodialysis, implanted1 recall0 reports
Recent Palindrome adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 26, 2026
INJURY OCCURRED, PULMONARY AIR EMBOLUS. DURING PLACEMENT OF TUNNELED CENTRAL VENOUS CATHETER, THE PEEL AWAY SHEATH VALVE FAILED AND A LARGE BOLUS OF AIR WAS SUCKED INTO THE SHEATH AND INTO THE HEART PROMPTING IMMEDIATE ADVANCED AIRWAY PROCEDURES, PATIENT REPOSITIONING, AND EMERGENT ANESTHESIA RESPONSE.
Patient problems: Hemodynamic instability; Obstruction/Occlusion; Pulmonary Embolism; Reduced Blood Flow
MAUDE report 25277324 ↗MalfunctionMar 11, 2026Break
ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT AS PER MEDICAL ORDERS, THE CENTRAL VENOUS CATHETER PORT WAS RUPTURED. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 24575046 ↗InjuryJan 27, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE ENTIRE ARTERIAL LUER END DETACHED FROM THE CATHETER DURING DIALYSIS; NO ONE WAS ACTIVELY TOUCHING THE LINE AT THAT TIME. THE LUER LOCK CONNECTION REMAINED SECURE, AND THE LUER END CAME AWAY WITH THE DIALYSIS LINE. LINE INFECTION FOLLOWING DETACHMENT. THE ADMISSION FOR THE LINE WAS EXCHANGE. THE NURSE WAS BESIDE THE PATIENT SWAPPING DIALYSIS CANISTERS AND WAS ABLE TO IMMEDIATELY CLAMP THE LINE WITH THE FINGERS AND LINE CLAMP TO PREVENT BLOOD LOSS. THE NURSE CLAMPED THE LINE WITH THE CLAMP IN HAND. THE PATIENT WAS IMMEDIATELY TRANSFERRED TO THE HOSPITAL. THE NEW LUMEN WAS INSERTED, AND THE PATIENT WAS ADMITTED FOR LINE EXCHANGE IN RADIOLOGY. THE PATIENT DEVELOPED A BACTEREMIA FOLLOWING THE INCIDENT. THE CATHETER WAS NOT REPAIRED. THE CLEANING AGENT USED ON THE DEVICE WAS 2% CHLORHEXIDINE IN 70% ALCOHOL (CHLORPREP USED FOR THE EXIT SITE, HEXIHUB CLINELL WIPES) USED FOR CONTACT TIME DISINFECTION OF THE DEVICE. THE PRODUCT WAS TESTED/INSPECTED PRIOR TO USE. THE PATIENT WAS ALIVE AND STABLE.
Patient problems: Bacteremia
MAUDE report 24189976 ↗MalfunctionDec 22, 2025Break; Separation Problem; Break; Separation Problem
ACCORDING TO THE REPORTER, DURING THE PROCEDURE OF SUBCUTANEOUS PUNCTURE, IMMEDIATELY PRIOR TO INSERTING THE CATHETER INTO THE PATIENT, THE SYMMETRIC TIP CATHETER WAS BROKEN. THERE WAS NO IMPACT ON THE PATIENT'S VITAL SIGNS. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. NO EXCESSIVE FORCED USE ON THE DEVICE. AS A REMEDIAL ACTION, A NEW SET OF CONSUMABLES WAS DISASSEMBLED. THE PROCEDURE WAS ABLE TO PROCEED AND WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23868750 ↗DeathDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE ENTIRE VENOUS LUER END DETACHED FROM THE CATHETER DURING DIALYSIS. THE LUER LOCK CONNECTION REMAINED SECURE, AND THE LUER END CAME AWAY WITH THE DIALYSIS LINE. THE PRODUCT WAS TESTED/INSPECTED PRIOR TO USE. THE NURSES ATTENDED TO THE PATIENT ON HEARING A COUGHING SOUND AND FOUND BLOOD LOSS AROUND THE PATIENT. RESUSCITATION COMMENCED AND CONTINUED BY PARAMEDICS BUT WAS UNSUCCESSFUL.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23849602 ↗MalfunctionDec 11, 2025Break; Break
ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, LOCKED WAS REMOVED AND ARTERIAL LUMEN FLUSHED SUCCESSFULLY. THE VENOUS LUMEN WITH 10 MILLILITERS FLUSH OF SALINE LEAKED BACK DOWN VIA THE EXIT SITE. THE PATIENT WAS SITTING UPRIGHT AT THE TIME. THE SECOND 10 ML FLUSH ATTEMPTED TO DIAGNOSE, AND THE SAME THING HAPPENED. UNABLE TO FIND SOURCE OF LEAK AS ABOVE EXIT SITE IN THE TUNNEL. CATHETER DEEMED UNUSABLE AND NOT ACCESSED AGAIN. THEY ATTENDED THE FOLLOWING BLOOD TESTS: FULL BLOOD COUNT, RENAL BIOCHEMISTRY AND C-REACTIVE PROTEIN. PATIENT WAS DEEMED STABLE AND WAS DISCHARGED HOME. TREATMENT WAS NOT CONTINUED, AND THE DECISION WAS MADE TO NOT IMPLANT ANOTHER CATHETER, BUT TO ATTEMPT TO USE ANOTHER CATHETER INSERTED ON THE SAME DAY AS THE ORIGINAL CATHETER IMPLANT FOR DIALYSIS. THEY CHANGED THE CENTRAL VENOUS ACCESS DEVICE (CVAD) DRESSINGS THREE TIMES A WEEK UNTIL REMOVAL AS PATIENT HAD BLOOD OOZING FROM EXIT SITE SPORADICALLY, AND THE DRESSINGS WERE LIFTING DUE TO THE HEAT. THE PATIENT HAD CHANGED THE DRESSING AT HOME WITHIN THE FIRST WEEK AND WAS ADVISED TO PRESENT TO THE UNIT RATHER THAN DO IT ALONE. THEY USE CHLORHEXIDINE AND ALCOHOL TO CLEAN THE ACCESS SITE AND KALTOSTAT/AMD FOAM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23782991 ↗MalfunctionDec 3, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
ACCORDING TO THE REPORTER, DURING THE INTERVENTIONAL RADIOLOGY PROCEDURE IN THE HEMODYNAMICS AREA OF THE HOSPITAL, FOLLOWING ASEPSIS AND ANTISEPSIS UNDER SEDATION, THE CATHETER WAS PLACED IN THE LEFT JUGULAR VEIN. FOLLOWING PUNCTURE, TUNNELING, AND ADVANCEMENT OF THE CATHETER TO THE RIGHT ATRIUM UNDER FLUOROSCOPIC AND ULTRASOUND GUIDANCE, AND PROGRESSIVE DILATION TO 15 FRENCH, LEAVING A PEEL AWAY 15 FRENCH INTRODUCER. THE CATHETER WAS THEN TUNNELED FROM THE LEFT SUPRACLAVICULAR PORTION INTO THE LEFT JUGULAR REGION, WHERE THE 14.5 X 23 CATHETER INTRODUCER WAS PLACED AND LEFT IN THE VEIN. THE CATHETER WAS TESTED FOR ARTERIAL LUMEN DYSFUNCTION, AND THE PATENCY AND BLOOD RETURN TESTS WERE UNSUCCESSFUL. KINKING WAS RULED OUT BY FLUOROSCOPY. EVEN THOUGH TRACTION MANEUVERS WERE PERFORMED TO MODIFY THE CATHETER ANGULATION, VENOUS RETURN DID NOT IMPROVE. IT WAS OBSERVED THAT THE CATHETER WAS DYSFUNCTIONAL. THE LINE WAS NOT HARD TO FLUSH WITH THE SYRINGE, AND THERE WAS NO BLOOD RETURN PRIOR TO SYRINGE FLUSH. HEPARIN WAS USED AS AN ANTICOAGULANT DURING THE PROCEDURE, AND REVERSE FLOW WAS UNSUCCESSFUL. THE CATHETER WAS FLUSHED BEFORE INSTALLATION WITHOUT ANY ISSUES. NO OTHER PRODUCTS WERE UTIL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23711463 ↗MalfunctionNov 26, 2025Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE REPORTER, UPON DISCONNECTION, A BLOOD STAIN WAS OBSERVED ON THE STERILE DRAPE, AND BLOOD WAS NOTED AROUND THE VENOUS CLAMP OF THE DIALYSIS CATHETER. AFTER CLEANING THE CLAMP, NOTHING ABNORMAL WAS VISIBLE. FLUSHING OF THE VENOUS BRANCH SHOWED NO ISSUES EITHER. HOWEVER, DURING A PRESSURIZED FLUSH OF THE VENOUS BRANCH WITH THE CLAMP CLOSED AND SALINE SYRINGE INJECTED UNDER PRESSURE, A LEAK WAS IMMEDIATELY OBSERVED AT THE BRANCH LEVEL. THE CATHETER WAS NOT REPAIRED. THERE WAS A LEAK AT THE CATHETER SHAFT. THERE WAS NO LEAKING AT THE JUNCTION OF THE BIFURCATE AND CATHETER. ONLY STERILE SALINE (PHYSIOLOGICAL SERUM) WAS USED. NO CHEMICAL CLEANING AGENTS WERE APPLIED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653708 ↗MalfunctionNov 17, 2025Break; Break
ACCORDING TO THE REPORTER, DURING USE, THE CATHETER TIP WAS RUPTURED, AND THE HOSPITAL MONITORED AND REPORTED THE SAFETY INCIDENT AND ADVERSE REACTIONS. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23568296 ↗MalfunctionNov 13, 2025Break; Break
ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, AFTER THE CATHETER HAD BEEN IMPLANTED, IT WAS FOUND TO HAVE A CRACK AT THE LUER CONNECTOR. THE CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE WITH NORMAL RESULT. THERE WERE OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. AS A REMEDIAL ACTION AND INTERVENTION/TREATMENT, THE CATHETER WAS REPLACED. THE PROCEDURE WAS CONTINUED AND COMPLETED. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23550414 ↗MalfunctionNov 13, 2025Break; Break
ACCORDING TO THE REPORTER, DURING USE, THE CATHETER'S TIP GOT BROKEN. IT WAS ALSO STATED THAT A CRACK WAS OBSERVED AT THE LUER ADAPTER. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 23550295 ↗MalfunctionNov 13, 2025Break; Break
ACCORDING TO THE REPORTER, TEN DAYS AFTER CATHETER INSERTION, THE CATHETER CONNECTOR RUPTURED, PREVENTING THE PATIENT FROM RECEIVING NORMAL DIALYSIS. THE PATIENT COMPLAINED TO THE HOSPITAL. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THE TYPE OF CLEANING AGENT USED ON THE DEVICE WAS IODINE SOLUTION. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23549615 ↗MalfunctionNov 13, 2025Break; Break
ACCORDING TO THE REPORTER, THE CATHETER WAS USED FOR ONE MONTH AND WHILE ON THE DIALYSIS THE CONNECTOR WAS RUPTURED. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543259 ↗MalfunctionNov 12, 2025Break; Break
ACCORDING TO THE REPORTER, AFTER CATHETERIZATION, THE PATIENT USED IT FOR LESS THAN 1 MONTH, AND DURING DIALYSIS TREATMENT, THE BLUE LUER ADAPTER/HEAD WAS CRACKED (BROKEN TIP). IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. IODOPHOR WAS TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE, AND THE RESULT WAS NORMAL. BLOOD VESSEL WAS THE OTHER PRODUCT BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT. THE TUBE/CATHETER WAS REPLACED AS A MEDICAL INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT TO ADDRESS THE ISSUE. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23539115 ↗MalfunctionNov 12, 2025Break; Break
ACCORDING TO THE REPORTER, DURING USE, THE TIP BROKE AFTER CATHETER INSERTION. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS A LUER ADAPTER ISSUE AND IT WAS ALSO STATED THAT A CRACK WAS OBSERVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23538655 ↗
Other Mozarc Medical US LLC products
All Mozarc Medical US LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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