L-CathTM PICC S/L 28 GA (1.2F) x 25cmRecalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 00886333209910), received between May 14, 2020 and Sep 30, 2026 — classified as 1 death, 18 injuries, 96 malfunctions.

The most frequently reported specific device problem is “Crack” (34 reports).

1 FDA recall record name this device's identifier, 1 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, 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 15, 2026Class IIOpen, Classified

   Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.

   Z-2803-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 115 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Break

  Occurred less than 24h post insertion: PICC line leaking despite hub being tightened and dressing redressed, entire dressing saturated and lifting off less than 30 minutes post dressing change. Discussed with neonatologist, plan to rewire PICC with new line. Cleaned and draped in usual fashion. Dilator introduced without incidence. Gentle steady pressure used to withdraw line with moderate resistance felt. Leg massaged while firm, but gentle pressure applied to line. Line spontaneously snapped with no line exposed. A total of 8 cm of line broke off/ removed from infant. Line initially trimmed to 20 cm at time of insertion; therefore, 12 cm left inside infant. Neonatologist aware of line snapping immediately. Unexpected or prolonged care was required. It is unknown if there was patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50948238 ↗
• InjuryJul 29, 2026Leak/Splash

  Reporter stated that since the new design of the 28g argon catheters, the extension/PICC connection has been leaking repeatedly, even though the extension ring remains screwed on, regardless of the catheter batch number. The impact included loss of the catheter and time for reinsertion of a new PICC line. Re-sedation and pain/discomfort for the baby. Additional time required for the procedure.

  Patient problems: Discomfort

  MAUDE report 50075167 ↗
• InjuryJul 29, 2026Leak/Splash

  Reporter stated that since the new design of the 28g argon catheters, the extension/PICC connection has been leaking repeatedly, even though the extension ring remains screwed on, regardless of the catheter batch number. The impact included loss of the catheter and time for reinsertion of a new PICC line. Re-sedation and pain/discomfort for the baby. Additional time required for the procedure.

  Patient problems: Discomfort

  MAUDE report 50074879 ↗
• InjuryJul 29, 2026Leak/Splash

  Reporter stated that since the new design of the 28g argon catheters, the extension/PICC connection has been leaking repeatedly, even though the extension ring remains screwed on, regardless of the catheter batch number. The impact included loss of the catheter and time for reinsertion of a new PICC line. Re-sedation and pain/discomfort for the baby. Additional time required for the procedure.

  Patient problems: Discomfort

  MAUDE report 50074667 ↗
• MalfunctionFeb 11, 2026Fracture

  THE PRODUCT CONCERN WAS REPORTED BY A CLINICAL EDUCATOR INDICATING "PICC LINE WAS BEING PULLED BACK TO BE IN A MID-LINE POSITION WHEN THE PICC NURSE WENT TO REDRESS THE LINE AND REMOVE THE OLD TEMPORARY DRESSING, LINE SEEMED THE SHEAR IN HALF. PLEASE RESEARCH IF THIS HAS BEEN AN ISSUE WITH THIS PRODUCT AT OTHER FACILITIES. WE HAVE NOT HAD THIS HAPPEN TO US BEFORE.¿

  Patient problems: Insufficient Information

  MAUDE report 24319658 ↗
• MalfunctionJan 9, 2026Break

  A CLINICAL EDUCATOR REPORTED ¿PICC LINE WAS BEING PULLED BACK TO BE IN A MID-LINE POSITION WHEN THE PICC NURSE WENT TO REDRESS THE LINE AND REMOVE THE OLD TEMPORARY DRESSING, LINE SEEMED THE SHEAR IN HALF. PLEASE RESEARCH IF THIS HAS BEEN AN ISSUE WITH THIS PRODUCT AT OTHER FACILITIES. WE HAVE NOT HAD THIS HAPPEN TO US BEFORE.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022091 ↗
• InjuryJan 7, 2026Leak/Splash

  REPORTER STATED "PICC DRESSING NOTICED TO NEED CHANGING ON (B)(6) CLOSE TO MIDNIGHT. SAME DONE. DRESSING WAS NOTED TO BE WET AT THAT TIME. CONNECTIONS TIGHTENED AND PICC RESECURED. ON (B)(6) AT CLOSE TO 2300HRS, DRESSING NOTED TO HAVE A YELLOW TINGE IN COLOR. FELT TO BE DAMP. (B)(6) CALLED. DRESSING LIFTED. PICC LINE FLUSHED WITH NORMAL SALINE AND DRIPPING NOTED AT THE HUB OF THE PICC LINE WHERE IT TAPERS DOWN FROM THE HUB TO THE LINE PATIENT HAD TO BE POKED FOR A PIV ON REMOVAL OF THE PICC LINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996430 ↗
• InjuryNov 21, 2025Leak/Splash; Leak/Splash

  A NURSE REPORTED THAT DURING ASSESSMENT A PATIENTS PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE DRESSING NOTED TO BE SATURATED WITH FLUID AND LIFTING. UPON CLOSER INSPECTION FLUID LEAKING AT CONNECTION BETWEEN PICC LINE HUB AND EXTENSION TUBING. TUBING ADEQUATELY TIGHTENED. THE TUBING WAS CHANGED TO TRY AND RESOLVE ISSUE BUT PERSISTENTLY LEAKING WHEN FLUSHED WITH NS AND SLOWLY BEADING AND DRIPPING FROM HUB. HUB OF PICC LINE NOTED TO NOT BE PERFECTLY ROUND BUT MORE OVAL SHAPED. DATE IMPLANTED: (B)(6) 2025. WOULD NEED TO REPLACE PICC LINE TO FULLY RECTIFY ISSUE. LEVEL OF EFFECT: TEMPORARY HARM - FLUIDS WERE NOT BEING INFUSED AS ORDERED. IT IS UNKNOWN IF THE PICC LINE WAS REPLACED. THE SAMPLE IS NOT AVAILABLE FOR RETURN.

  Patient problems: Insufficient Information

  MAUDE report 23619203 ↗
• MalfunctionSep 15, 2025Fluid/Blood Leak; Obstruction of Flow

  IT WAS NOTED THAT THE ARGON PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] WAS LEAKING. SEE PROCEDURE NOTE FOR LOT NUMBER. AFTER THE LEAKING WAS NOTED, THIS RN AND [REDACTED] WERE ATTEMPTING TO FIND WHERE THE LEAK WAS COMING FROM. THE T CONNECTOR WAS INTACT AND SECURE, BUT LEAKING WAS NOTED AT THE T CONNECTOR/PICC CONNECTION. AFTER CHANGING THE T CONNECTOR (BD MAXZERO), TAKING OFF THE POSI FLOW, WE WERE UNABLE TO FLUSH THE PICC AS IT HAD NOW CLOTTED OFF. THIS RN NOTIFIED [REDACTED] IN CHARGE OF BABE'S CARE AND [REDACTED] LEADER OF PICC TEAM. THEY ATTEMPTED TO FLUSH PICC AND WERE UNSUCCESSFUL ALSO. AT THIS TIME, WE HAD TO PULL THE PICC. WE ATTEMPTED TO PLACE A PICC LINE 3X AND WERE UNSUCCESSFUL. A SCALP PIV [PERIPEHERAL INTRAVENOUS LINE] WAS PLACED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23051145 ↗
• MalfunctionSep 5, 2025Crack; Entrapment of Device

  DURING PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINE INSERTION THE STYLET WAS TO BE SLIGHTLY REMOVED TO ALLOW FOR COMPLETE INSERTION OF PICC LINE INTO LEFT SAPHENOUS VEIN. WHEN PICC TRAINED RN ATTEMPTED TO MOVE THE WHITE "PLUG" ON THE END OF THE PICC AND STYLET, THE WHITE "PLUG" CRACKED IN HALF, ALLOWING THE STYLET TO BE REMOVED BUT LEAVING PART OF THE WHITE "PLUG" IN THE END OF THE PICC LINE. THIS PIECE WOULD NEED TO BE REMOVED OTHERWISE THE PICC WOULD BE UNABLE TO BE USED AND UNABLE TO HOOK UP TO FLUID LINES. THE PICC TRAINED RN WAS ABLE TO USE JEWELER TO PRY THE WHITE "PLUG" FROM THE END OF THE PICC. HAD THIS NOT BEEN THE CASE, THE PICC WOULD HAVE HAD TO BE REMOVED, THEREFORE CAUSING HARM TO THE PATIENT BY NEEDING ANOTHER PICC PLACED THUS ANOTHER POKE, CREATING RISK FOR INFECTION AND POSSIBILITY OF NOT GAINING IV ACCESS NEEDED FOR ADEQUATE ANTIBIOTIC COVERAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977406 ↗
• MalfunctionAug 12, 2025Leak/Splash; Leak/Splash

  CUSTOMER REPORTS THAT THEY ARE STILL SEEING SOME LEAKING FROM L-CATHS. THEY TRIED SWITCHING FROM ICU MEDICAL EXTENSION SETS TO B-BRAUN EXT SETS BUT THEY ARE STILL SEEING MINOR LEAKING. THEY SAY IT HAS BEEN VERY INCONSISTENT. THEY CURRENTLY HAVE NO AFFECTED PRODUCT AVAILABLE FOR RETURN. WORTH NOTING THAT THIS IS A VERY EXPERIENCED PICC TEAM.

  Patient problems: Insufficient Information

  MAUDE report 22786696 ↗
• InjuryJun 12, 2025Leak/Splash; Leak/Splash

  THE PICC LEAKED AT THE JUNCTURE OF THE HUB AND THE MICROBORE EXTENSION SET. THIS HAPPENED THREE TIMES AND THE PICC HAD TO BE EXCHANGED EACH TIME THE PICC LEAKED.

  Patient problems: Insufficient Information

  MAUDE report 22197948 ↗
• MalfunctionJun 5, 2025Leak/Splash; Leak/Splash

  A PICC WAS PLACED FROM ARGON LOT NUMBER 11598928 ON (B)(6). ON (B)(6) A NURSE NOTICED LEAKING FROM THE SAME AREA AS OTHER PICC S HAVE SHOWN TO LEAK. JUST AS IN THE OTHER INSTANCES, A HUMMI WAS ADDED AND THE LEAKING SUBSIDED. THE PICC STAYED IN PLACE UNTIL (B)(6), WHEN IT WAS REMOVED WITHOUT FURTHER LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155242 ↗
• MalfunctionMay 19, 2025Leak/Splash; Leak/Splash

  FIVE CASES WHERE THE CATHETER DISCONNECTS UNEXPLAINEDLY CAUSING THE IV FLUID TO LEAK OUT OF THE PATIENT. EXPERIENCED NURSES HAVE NOTICED THAT THE TIP OF THE CATHETER IS DIFFICULT TO SCREW ONTO THE NEEDLELESS CONNECTOR AND THEREFORE ONTO THE IV EXTENSION AND TUBING.

  Patient problems: Insufficient Information

  MAUDE report 22047643 ↗
• MalfunctionMay 13, 2025Leak/Splash; Leak/Splash

  ¿THE CATHETER IN PARTICULAR WE HAVE EXPERIENCED THIS WITH IS THE L-CATH 28G INTRODUCER/ 1.2 SINGLE LUMEN PICC LINE." ¿AT TIMES WE ARE CONCERNED THAT THE HUB ON THE PICC LINE IS CRACKED WHICH HAS CAUSED LEAKING; ALSO, AT TIMES THE TUBING WE TYPICALLY USE FOR PICC LINE EXTENSION HAS BEEN LEAKING ONCE WE HOOK IT UP TO THE PICC LINE (AS SOON AS WE USE OUR NORMAL PIV TUBING THE LEAKING STOPS). IT HAS HAPPENED ENOUGH TIMES THAT I WANTED TO REACH OUT AND SEE IF YOU HAD ANY SUGGESTIONS FOR US IN REGARD TO THIS PARTICULAR LINE LEAKING AND SITE CARE.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009987 ↗
• MalfunctionMay 2, 2025Leak/Splash; Leak/Splash

  PICC FOUND TO BE LEAKING AT THE CONNECTION SITE AFTER BEING PLACED IN THE PATIENT. UNEXPECTED/PROLONGED CARE WAS REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955469 ↗
• InjuryApr 21, 2025Material Fragmentation; Material Fragmentation

  REPORTER STATED "PICC CATHETER ADVANCED THROUGH INTRODUCER. RESISTANCE MET. AS CATHETER WAS RETRACTED, NOTED CATHETER HAD BROKEN OFF AND GUIDEWIRE WAS EXPOSED. REMAINDER OF CATHETER REMOVED, CHEST X-RAY OBTAINED. CATHETER FRAGMENT NOTED AND INFANT TRANSFERRED TO CHOM FOR REMOVAL OF RETAINED FRAGMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21877170 ↗
• InjuryApr 21, 2025Break; Break

  A NURSE REPORTED "PRODUCT BROKE OFF DURING REMOVAL. PATIENT WENT TO CARDIAC CATH LAB FOR REMOVAL. ALL PRODUCT REMOVED FROM NICU."

  Patient problems: Insufficient Information

  MAUDE report 21876991 ↗
• MalfunctionMar 26, 2025Leak/Splash; Leak/Splash

  PICC LINE LEAKED UPON PLACEMENT AT THE HUB AND HAD TO BE REMOVED. A NEW PICC WAS PLACED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699181 ↗
• InjuryFeb 18, 2025Crack; Crack

  ¿LEAK¿ ¿AT HUB¿ ¿LINE HAD TO BE PULLED¿ DURATION: ¿<1HR¿ NOTES: ¿PICC LINE INSERTED AND ABLE TO BE ADVANCED WITHOUT ISSUE. WHEN I WENT TO FLUSH THE LINE, IT WAS LEAKING AT THE HUB. TRIED TO TIGHTEN X 2 AND THEN IT CONTINUED TO LEAK. PLACED MEDLINE TUBING AND HUB CONTINUED TO HAVE LEAKAGE WITH FLUSH. TRIED ANOTHER MED LINE TUBING AND IT ALSO CONTINUED TO LEAK. LINE WAS PULLED. HUB DID NOT APPEAR TO BE CRACKED.¿

  Patient problems: Insufficient Information

  MAUDE report 21401206 ↗
• InjuryFeb 5, 2025Break; Break

  REPORTER INDICATED PICC LINE SEVERED ON INSERTION AND A PORTION WAS RETAINED BY THE PATIENT. NO DEVIATIONS IN THE PROPER USE OF THE EQUIPMENT WERE IDENTIFIED FROM OUR REVIEW. PICC CATHETER CHECKED PRIOR TO INSERTION, 1.2 FR L-CATH, LENGTH = 25 CM. PICC CATHETER BEING INSERTED VIA LT SAPHENOUS VEIN, RESISTANCE NOTED AT GROIN AREA, SLOW EXTRACTION OF CATHETER DONE AND OBSERVED GUIDE WIRE BEING VISIBLE. CATHETER MARKING 15.5 CM WHERE GUIDE WIRE IS VISIBLE, ORIGINAL CATHETER LENGTH 25 CM. MOST RESPONSIBLE PHYSICIAN CALLED IMMEDIATELY. STAT X-RAY DONE, CATHETER VISIBLE IN LT LEG, IGT CONTACTED IMMEDIATELY. ULTRASOUND DONE BY IGT FELLOW AND PLANS MADE FOR REMOVAL. OF NOTE, THE RETAINED PORTION WAS REMOVED WITHOUT COMPLICATION OR FURTHER HARM TO THE INFANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21316129 ↗
• MalfunctionJan 27, 2025Leak/Splash; Leak/Splash

  REPORTER INDICATED SHORTLY AFTER SUCCESSFUL PLACEMENT NOTICED THE DRESSING WAS SATURATED. UPON INSPECTION, THE HUB DID NOT APPEAR TO BE CRACKED SO THEY CHANGED THE EXTENSION SET AND DRESSING. AFTER A TIME NOTICED THE DRESSING WAS AGAIN WET (TO THE POINT OF SLIDING). INSPECTED THE HUB AND AGAIN, DIDN¿T APPEAR TO BE CRACKED. CHANGED THE EXTENSION SET AGAIN. EVENTUALLY SWITCHED TO A NEEDLESS CONNECTOR THAT APPEARED TO BE WORKING AS OF THE MORNING OF 12/9/24. PICCS ARE STILL IN-DWELLING (WILL BE SAVED TO SEND IN WHEN LINES ARE PULLED) AS OF NOW. THEY SWITCHED TO PUTTING IN THEIR BACKUP FOOTPRINT 28G AND NOTED THAT THEY HAVE HAD NO ISSUES WITH THE SAME EXTENSION SETS. WAS ALSO NOTED THAT SEEMED TO BE FINE WITH 1-2ML/HR FLOW, BUT WHEN FLOW WAS INCREASED TO 17ML/HR LEAKING OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21248062 ↗
• MalfunctionJan 27, 2025Leak/Splash; Leak/Splash

  REPORTER STATED SHORTLY AFTER SUCCESSFUL PLACEMENT NOTICED THE DRESSING WAS SATURATED. UPON INSPECTION, THE HUB DID NOT APPEAR TO BE CRACKED SO THEY CHANGED THE EXTENSION SET AND DRESSING. AFTER A TIME NOTICED THE DRESSING WAS AGAIN WET (TO THE POINT OF SLIDING). INSPECTED THE HUB AND AGAIN, DIDN'T APPEAR TO BE CRACKED. CHANGED THE EXTENSION SET AGAIN. EVENTUALLY SWITCHED TO A NEEDLESS CONNECTOR THAT APPEARED TO BE WORKING AS OF THE MORNING ON (B)(6) 2024. PICCS ARE STILL IN-DWELLING (WILL BE SAVED TO SEND IN WHEN LINES ARE PULLED) AS OF NOW. THEY SWITCHED TO PUTTING IN THEIR BACKUP FOOTPRINT 28G AND NOTED THAT THEY HAVE HAD NO ISSUES WITH THE SAME EXTENSION SETS. WAS ALSO NOTED THAT SEEMED TO BE FINE WITH 1-2ML/HR FLOW, BUT WHEN FLOW WAS INCREASED TO 17ML/HR LEAKING OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21247448 ↗
• MalfunctionJan 27, 2025Leak/Splash; Leak/Splash

  REPORTER STATED SHORTLY AFTER SUCCESSFUL PLACEMENT NOTICED THE DRESSING WAS SATURATED. UPON INSPECTION, THE HUB DID NOT APPEAR TO BE CRACKED SO THEY CHANGED THE EXTENSION SET AND DRESSING. AFTER A TIME NOTICED THE DRESSING WAS AGAIN WET (TO THE POINT OF SLIDING). INSPECTED THE HUB AND AGAIN, DIDN'T APPEAR TO BE CRACKED. CHANGED THE EXTENSION SET AGAIN. EVENTUALLY SWITCHED TO A NEEDLESS CONNECTOR THAT APPEARED TO BE WORKING AS OF THE MORNING OF (B)(6) 2024. PICCS ARE STILL IN-DWELLING (WILL BE SAVED TO SEND IN WHEN LINES ARE PULLED) AS OF NOW. THEY SWITCHED TO PUTTING IN THEIR BACKUP FOOTPRINT 28G AND NOTED THAT THEY HAVE HAD NO ISSUES WITH THE SAME EXTENSION SETS. WAS ALSO NOTED THAT SEEMED TO BE FINE WITH 1-2ML/HR FLOW, BUT WHEN FLOW WAS INCREASED TO 17ML/HR LEAKING OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246739 ↗
• MalfunctionJan 27, 2025Leak/Splash; Leak/Splash

  REPORTER STATED SHORTLY AFTER SUCCESSFUL PLACEMENT NOTICED THE DRESSING WAS SATURATED. UPON INSPECTION, THE HUB DID NOT APPEAR TO BE CRACKED SO THEY CHANGED THE EXTENSION SET AND DRESSING. AFTER A TIME NOTICED THE DRESSING WAS AGAIN WET (TO THE POINT OF SLIDING). INSPECTED THE HUB AND AGAIN, DIDN¿T APPEAR TO BE CRACKED. CHANGED THE EXTENSION SET AGAIN. EVENTUALLY SWITCHED TO A NEEDLESS CONNECTOR THAT APPEARED TO BE WORKING AS OF THE MORNING OF (B)(6) 2024. PICCS ARE STILL IN-DWELLING (WILL BE SAVED TO SEND IN WHEN LINES ARE PULLED) AS OF NOW. THEY SWITCHED TO PUTTING IN THEIR BACKUP FOOTPRINT 28G AND NOTED THAT THEY HAVE HAD NO ISSUES WITH THE SAME EXTENSION SETS. WAS ALSO NOTED THAT SEEMED TO BE FINE WITH 1-2ML/HR FLOW, BUT WHEN FLOW WAS INCREASED TO 17ML/HR LEAKING OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246644 ↗