VASCU-PICC® MD17012601 (UDI 00884908146493)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00884908146493), received between Feb 3, 2021 and Apr 29, 2025 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (18 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Leak/Splash; Leak/Splash

  THE PATIENT'S PICC LINE WAS NOT DRAWING BACK. THE PATIENT'S LEG HAD A HARD SWOLLEN SPOT. THE LINE WAS REMOVED DUE TO CONCERN OF INFILTRATION. WHEN THE LINE WAS PULLED, THERE WAS A FRACTURE IN THE LINE THAT LOOKED TO BE ABOUT WHERE THE SWELLING WAS ON THE PATIENT'S LET. INFILTRATION WAS MODERATE. NO ADDITIONAL INTERVENTIONS WERE REQUIRED. NO HARM TO THE PATIENT WAS NOTED.

  Patient problems: Swelling/ Edema

  MAUDE report 21927207 ↗
• MalfunctionJan 2, 2025Leak/Splash; Leak/Splash

  PATIENT WAS RECEIVING MEDICATIONS MEANT FOR CENTRAL INES ONLY DUE TO THEIR RISK OF EXTRAVASATION. PATIENT'S LEFT ARM STARTED SWELLING AROUND THE PICC SIT. RN NOTIFIED MD AND AN ULTRASOUND WAS ORDERED AND DID NOT SHOW A DVT. RN CONSULTED WITH VASCULAR ACCESS AND MD AND ASKED IF THE INFUSING TPN/LIPIS SHOULD BE MOVED TO ANOTHER LINE IF THERE WAS SUSPICION OF THE LINE BEING CRACKED. THE LINE STILL HAD BRISK BLOOD RETURN SO THEY WERE PRETTY SURE THE SWELLING WAS NOT RELATED TO EXTRAVASATION. WHEN RN RETURNED TO WORK NIGHT SHIFT THE LEFT ARM WAS MORE SWOLLEN, THE SKIN WAS TAUGHT, AND THE SWELLING HAD SPREAD TO THE LEFT CHEST, LEFT BACK, AND DOWN THE LOWER LEFT ARM WITH A NEW BRUISE. RN CONSULTED VASCULAR ACCESS WHO CAME AND ASSESSED THE LINE. SHE RECOMMENDED ANOTHER ULTRASOUND WITH THE PICC AND CENTRAL LINE DRESSINGS REMOVED TO ASSESS UNDER THE DRESSING. THE ULTRASOUND WAS NEGATIVE FOR A CLOT BUT THE SWELLING CONTINUED TO WORSEN. AT THIS POINT NORMAL SALINE WAS RUNNING THROUGH BOTH LUMENS AT A TOTAL OF 5 ML/HR. VANCOMYCIN WAS ORDERED AND STARTED IN CASE THIS WAS CELLULITIS. A FEW HOURS LATER THE PUMP BEEPED THAT IT WAS OCCLUDED AND THE RN FLUSHED AND CHECKED FOR BLOOD RETURN. THERE WAS

  Patient problems: Swelling/ Edema

  MAUDE report 21056471 ↗
• MalfunctionDec 12, 2024Leak/Splash; Leak/Splash

  RN STOPPED IVF AND HEPLOCK THE CATHETER. THE RED LUMEN WAS UNABLE TO BE FLUSHED. ALTEPLASE WAS ORDERED AND INSTILLED, BUT WITH GREAT DIFFICULTY. THE ATTEMPT TO REMOVE THE ALTEPLASE WAS MADE 2 HOURS LATER BUT VERY LITTLE WAS ABLE TO BE REMOVED. PICC WAS REMOVED 2 DAYS LATER. LINE DISCOVERED TO BE RUPTURED, LOOKING LIKE IT HAD SPLIT IN SEVERAL PLACES AND BUBBLED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912563 ↗
• MalfunctionNov 8, 2024Break; Break

  PATIENT HAD A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) PLACED. NURSE SAW BLEEDING AROUND THE SITE AND IDENTIFIED THAT THE PICC WAS BROKEN WHERE THE HUB AND CATHETER MET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645120 ↗
• MalfunctionOct 7, 2024Leak/Splash; Leak/Splash

  VASCU PICC WAS NOTED TO BE LEAKING APPROXIMATELY 1 CM BELOW THE SUTURE WING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20383477 ↗
• MalfunctionAug 9, 2024Leak/Splash; Leak/Splash

  DURING ASSESSMENT OF PICC LEAKAGE, IT WAS NOTED DETERMINED THAT THE RED LUMEN NOTED TO HAVE 2CM TEAR AROUND 10CM MARK. WHITE LUMEN INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19947810 ↗
• MalfunctionMay 20, 2024Leak/Splash; Leak/Splash

  LUE PICC PLACED A MONTH AGO WITH MULTIPLE VASCULAR ACCESS TEAM (VAT) CONSULTS DUE TO NO BLOOD RETURN ON RED LUMEN. SIX DOSES OF ALTEPLASE INSTILLED OVER EIGHT DAYS, FIRST FEW RESTORED PATENCY BUT TODAY, AFTER TWO UNSUCCESSFUL DOSES OF ALTEPLASE VAT REGISTERED NURSE (RN) REPORTED THAT SHE PLACED L-CYSTEINE IN LINE EVEN THOUGH NO INCOMPATIBLE MEDICATIONS WERE INFUSING OR HAVE BEEN INFUSING IN THE LAST SEVERAL DAYS. ASSESSMENT: REQUESTED X-RAY OF ENTIRE LINE PATH (LAST X-RAY WAS DONE THREE DAYS AGO) AND COMPARED WITH PREVIOUS IMAGES, THE LAST IMAGE THAT SHOWED THAT LINE WAS COMPLETELY INTACT. THE MOST RECENT TWO IMAGES SHOWED AN "UNUSUAL" "BULGE" IN LINE, NEAR AXILLARY REGION. TODAY, IMAGE SHOWS A CLEAR LARGE TEAR IN LINE NEAR AXILLA. AT BEDSIDE, ASSESSED SITE UNDER DRESSING AND FOUND DRAINAGE ON THE BIOPATCH FROM THE BACKFLOW / LEAKAGE. RESOLUTION: ALWAYS RULE OUT A MECHANICAL ISSUE WITH LINE IF OCCLUSION ISSUES CONTINUES DESPITE ALTEPLASE TX . R/O MECHANICAL ISSUES BY 1) TAKING DOWN DRESSING TO EVALUATE SITE 2) GET A CURRENT X-RAY OF ENTIRE LE PATH AND COMPARE IMAGES. NO LCYSTEINE NEEDED IF NO INCOMPATIBLE MEDICATIONS INFUSED. RUPTURED PICC LINE NOTED AFTER REMOVAL DUE TO REPEATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351877 ↗
• MalfunctionJan 31, 2024Leak/Splash; Leak/Splash

  THE EXTENSION WITH THE WHITE CLAMP WAS HEPARIN LOCKED. THE EXTENSION WITH THE RED CLAMP WAS INFUSING WITH A CARRIER SOLUTION OF NORMAL SALINE A 2 ML/HOUR AT THE TIME LEAKING WAS NOTED AT THE INSERTION SITE. WHEN THE INFUSION WAS DISCONNECTED AND THE EXTENSION WITH THE RED CLAMP WAS FLUSHED, LEAKING WAS NOTED FROM THE INSERTION SITE. THE EXACT LOCATION OF THE LEAK ON THE WHITE LUMEN WAS NOT REPORTED AND THE CATHETER WAS NOT SAVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616020 ↗
• MalfunctionJan 31, 2024Leak/Splash; Leak/Splash

  CONTINUOUS INFUSION WAS RUNNING THROUGH BOTH LUMENS OF THE CATHETER AT THE TIME THE LEAK WAS NOTED. THE SPECIFIC LOCATION OF THE LEAK WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616010 ↗
• MalfunctionJan 31, 2024Leak/Splash; Leak/Splash

  THE EXTENSION WITH THE WHITE CLAMP WAS HEPARIN LOCKED. THE EXTENSION WITH THE RED CLAMP WAS INFUSING WITH A CARRIER SOLUTION OF NORMAL SALINE AT 2 ML/HOUR AT THE TIME LEAKING WAS NOTED BENEATH THE DRESSING. WHEN THE DRESSING WAS TAKEN DOWN AND THE EXTENSION WITH THE RED CLAMP WAS FLUSHED, LEAKING WAS NOTED FROM THE WHITE LUMEN. HOWEVER, THE SPECIFIC LOCATION OF THE LEAK WAS NOT REPORTED. THE PICC WAS REMOVED AND A PERIPHERAL IV WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616004 ↗
• MalfunctionJan 22, 2024Leak/Splash; Leak/Splash

  DURING NIGHT SHIFT, PICC LINE WHITE LUMEN WAS LEAKING AT INSERTION SITE. DURING MORNING DAYSHIFT, PICC TEAM CAME TO REWIRE PICC LINE. AFTER REMOVAL, WHEN THE WHITE LUMEN IS FLUSHED, THE LINE LEAKS AT THE POINT WHERE THE INSERTION SITE WAS. PICC REWIRED AND SEQUESTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553177 ↗
• MalfunctionOct 2, 2023Leak/Splash; Leak/Splash

  PICC WAS PLACED ON (B)(6) 2023 AT 1000, LEFT BASILIC VEIN ON FIRST ATTEMPT. NO CATHETER ISSUES WERE IDENTIFIED UPON INSERTION AND THE CATHETER WAS HEPARIN LOCKED UNTIL FLUIDS WERE INITIATED. DOCUMENTATION INDICATES SOME SLUGGISH BLOOD RETURN INITIALLY UPON INITIATING INFUSION; HOWEVER, THEREAFTER, IT WAS INFUSING WITHOUT ISSUE. ON THE EVENING OF (B)(6) 2023, ALTEPLASE WAS INSTILLED INTO THE PROXIMAL (RED) LUMEN FOR SLUGGISH BLOOD RETURN. AFTER THE REQUIRED DWELL TIME, THE RN WAS UNABLE TO ASPIRATE THE ALTEPLASE. THE DRESSING WAS TAKEN DOWN TO CHECK THE CATHETER AND THE SITE WAS NOTED TO BE WET. UPON FLUSHING, THERE WAS LEAKAGE FROM THE RED PORT AT THE JUNCTION OF THE SECUREMENT WINGS. (LUMEN LEAK AT THE HUB) THE DISTAL (WHITE) LUMEN DID NOT LEAK WHEN FLUSHED AND THE RN WAS ABLE TO ASPIRATE BLOOD. THERE WAS NO CHANGE IN EXTERNAL CATHETER LENGTH AND CHEST X-RAY OBTAINED ON (B)(6) AT 1700 INDICATED CATHETER TIP POSITION WAS UNALTERED FROM TIME OF INSERTION. THE PICC WAS REMOVED ON (B)(6) 2023 AT 1923. REMOVAL CATHETER LENGTH INDICATED NO DISCREPANCY FROM INSERTION CATHETER LENGTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17856337 ↗
• MalfunctionSep 13, 2023Break; Leak/Splash; Break; Leak/Splash

  IV INFILTRATION WAS FOUND TO PATIENTS R BASILLIC PICC, ONCE PICC LINE WAS REMOVED THE LINE WAS FLUSHED TO INSPECT LINE PATENCY AND FLUID WAS SEEN COMING OUT OF THE TOP PORTION OF THE LINE FROM A TORN SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740161 ↗
• MalfunctionSep 7, 2023Break; Leak/Splash; Break; Leak/Splash

  PICC LINE RUPTURE, POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17701209 ↗
• MalfunctionAug 23, 2023Break; Leak/Splash; Break; Leak/Splash

  PICC LUMEN BURST APPROXIMATELY 1 CM BELOW THE HUB DURING INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17602805 ↗
• MalfunctionOct 11, 2022Break; Break

  POST PLACEMENT PROCEDURE, THE LINE CRACKED INTERNALLY AND HAD TO BE REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579550 ↗
• MalfunctionJul 27, 2022Break; Break

  INFORMATION OBTAINED FROM MEDWATCH (B)(4) FORWARDED TO MEDCOMP. LINE WAS DOCUMENTED AS HAVING BLOOD AND FLUID UNDER THE DRESSING AND WAS NOT FLUSHING WELL. WHEN THE DRESSING WAS TAKEN DOWN THE BEDSIDE NURSE IDENTIFIED THAT THE WAS LEAKING AND THE TEAM DECIDED TO REMOVE THE LINE AND JUST MOVE TO PIV INSTEAD OF REPLACING THE PICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15112189 ↗
• MalfunctionJul 8, 2022Break; Break

  BEDSIDE RN NOTICED LEAKAGE OF BLOOD TINGED IV FLUID AROUND DRESSING. PICC TEAM CALLED AND UPON ASSESSMENT NOTICED LEAKING AT INSERTION SITE WHEN FLUSHED WITH NS. REMOVED PICC AND UPON EXAMINATION, NOTICED A RUPTURED AREA THAT WAS UNDER THE INSERTION SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14957693 ↗
• InjuryDec 7, 2021Leak/Splash; Leak/Splash

  LINE WAS LEAKING IV FLUID AND BLOOD. PER THE RN, THE PATIENT WAS ALIVE AFTER THE LINE WAS REMOVED AND RECEIVED ANOTHER LINE. HOWEVER, THERE WAS A CLABSI SO SHE CANNOT BE CERTAIN THAT HAVING A LINE THAT WAS COMPROMISED HAD NO CONTRIBUTION.

  Patient problems: Insufficient Information

  MAUDE report 12954832 ↗
• MalfunctionMay 12, 2021Crack; Crack

  PLACED PICC. X-RAY OBTAINED. PULLED BACK CATHETER AND WAS UNABLE TO FLUSH. CATHETER REMOVED AND LINE FOUND TO BE CRACKED 2CM FROM TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813228 ↗
• MalfunctionFeb 19, 2021Leak/Splash; Leak/Splash

  BEDSIDE NURSE REPORTS BOTH LINES INFUSING THROUGHOUT THE DAY WITHOUT DIFFICULTY. INTERMITTENT ALARM TO WHITE LUMEN. TPA INFUSED TO WHITE LUMEN AND ALLOWED TO DWELL. UNABLE TO WITHDRAW AFTER APPROPRIATE DWELL TIME. PNP TO BEDSIDE, ATTEMPTED TO CLUSH WITH 10CC SYRINGE, OBSERVED LEAKING AT THE SITE. THE LINE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11350085 ↗
• MalfunctionFeb 3, 2021Leak/Splash; Leak/Splash

  LINE PLACED BY PICC TEAM TO LEFT BASILIC VEIN. BOTH LUMENS RUPTURED AT 1CM MARK (WHICH WAS AT THE SKIN EXIT SITE). THE PICC TEAM RECEIVED A CALL FROM THE ICU NURSE REPORTING WETNESS AT SITE. TWO PICC NURSES THEN WENT TO BEDSIDE, REMOVED DRESSING, AND WHILE FLUSHING LINE, OBSERVED LEAKING. AFTER A CONVERSATION WITH THE PHYSICIAN, LINE WAS REMOVED. PER THE BEDSIDE NURSE, THERE HAD BEEN NO PROBLEMS WITH THE LINE, BOTH LUMENS WERE INFUSING CONTINUOUSLY, AND SHE HAD COMPLETED A CAP CHANGE ON BOTH LUMENS EARLIER IN THE DAY, BOTH WITH POSITIVE BLOOD RETURN AND FLUSHING EASILY. THE NURSE WAS DRAWING LABS THIS AFTERNOON WHEN SHE OBSERVED "LEAKING" FROM THE SITE. UPON FURTHER INVESTIGATION, I OBSERVED BOTH LUMENS LEAKING AT THE FIRST BLACK LINE (1CM MARK).

  Patient problems: Insufficient Information

  MAUDE report 11272764 ↗
• MalfunctionFeb 3, 2021Leak/Splash; Leak/Splash

  LINE PLACED IN LEFT FEMORAL VEIN BY IR BOTH LUMENS RUPTURED BETWEEN THE 8CM AND 9CM MARK. THE NURSES REPORTED THAT THEY HAD BEEN HAVING TO TPA THE LINE FREQUENTLY TO OBTAIN LABS. A SONO WAS PERFORMED TO LOOK FOR ANY ANOMALIES AND WHAT APPEARED TO BE A THROMBUS WAS OBSERVED. PATIENT WAS BEING TREATED FOR THROMBUS AND IT WAS DETERMINED THAT DUE TO MULTIPLE TPA INFUSIONS AND COMPLICATIONS WITH THE LINE, THAT THE LINE NEEDED TO BE REMOVED. I THEN REMOVED THE LINE WITHOUT DIFFICULTY, AND OBSERVED A "FLATTENED" AREA BETWEEN THE 8CM MARK AND THE 9CM MARK. I BROUGHT THE LINE TO THE IR PHYSICIAN, AND UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT BOTH LUMENS APPEARED RUPTURED. THE IR PHYSICIAN REVIEWED THE SONO AND RADIOGRAPHIC FILMS, AND IT WAS THOUGHT THAT THE "RUPTURE" AREA WAS AT A FLEXION POINT AND THAT MAY HAVE BEEN THE CONTRIBUTING FACTOR FOR THE RUPTURES. THE LINE WAS THEN DISCARDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11272127 ↗