Vascu-PICC® MR17012601Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00884908085693), received between Mar 2, 2017 and Mar 12, 2025 — classified as 4 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionMar 12, 2025Leak/Splash; Leak/Splash

  PICC BECAME BLOCKED-TRIED FLUSHING LINE X 3. FINALLY ABLE TO FLUSH AND LINE APPEARED CRACKED AS DRESSING FILLED UP WITH FLUID/BLOOD. PICC CURRENTLY STILL IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584559 ↗
• MalfunctionMar 4, 2025Leak/Splash; Leak/Splash

  LEAK NOTED AT INSERTION SITE. DEVICE FOUND TO BE CRACKED WHEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21515831 ↗
• MalfunctionDec 6, 2022Break; Break

  PICC LEAKING AT SITE, REMOVED, FOUND TO HAVE A BLEB ~ 1CM FROM HUB AND CRACK ~ 2 CM FROM HUB. 21G LUMEN AFFECTED, 23G LUMEN SEEMS FINE. LINE INSERTED OCT 24, NEVER USED FOR BLOOD DRAWS AND NO REPORTED ISSUES WITH HIGH PRESSURES/FLUSHING LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926141 ↗
• MalfunctionApr 6, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  VASCULAR ACCESS TEAM (VAT) WAS REQUESTED TO EVALUATE PATIENT'S PICC DUE TO REPORT OF DIFFICULT ASPIRATION AND AIR BEING ASPIRATED FROM PICC. VAT ASSESSED PICC AND FOUND THAT THERE WAS NO BLOOD RETURN WITH ASPIRATION, BUT ONLY AIR. UNABLE TO IDENTIFY EVIDENCE OF FRACTURE; HOWEVER, UNABLE TO FLUSH THE LINE WITH AIR IN THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9930373 ↗
• MalfunctionMar 13, 2020No Apparent Adverse Event; No Apparent Adverse Event

  AFTER PLACING THE PICC LINE AN ATTEMPT WAS MADE TO FLUSH BOTH LUMENS. AS THE RED LUMEN WAS FLUSHED WITH THE T-PIECE/WIRE STILL CONNECTED TO THE END OF THE PICC, BLOOD BEGAN BACKING UP INTO THE OTHER WHITE LUMEN. PICC WAS REMOVED AND REPLACED WITH ANOTHER AND NO FURTHER ISSUES WERE NOTED.

  Patient problems: Not Applicable

  MAUDE report 9828726 ↗
• MalfunctionJan 28, 2020Leak/Splash; Leak/Splash

  PATIENT WAS FOUND TO HAVE A SATURATED DRESSING AT THE PICC SITE. THE CATHETER WAS REMOVED AND NOTED UPON FLUSHING TO HAVE A FRACTURE AT THE 1.5CM MARK.

  Patient problems: Swelling

  MAUDE report 9636436 ↗
• MalfunctionJan 23, 2020Break; Break

  HOSPITAL REPORTS THE RADIOLOGY TECHNICIAN WAS BEDSIDE RE-TAPING THE NASAL CANNULA. THE BABY WAS CRYING AND KICKING HIS LEGS. NURSE WENT TO HELP AND NOTICED THE 2.6F VASCU-PICC WAS BROKEN AT THE HUB AND LYING IN THE BED. THE REST OF THE CATHETER WAS REMOVED AND A NEW PERIPHERAL IV WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9621488 ↗
• MalfunctionMay 14, 2019Break; Break

  CATHETER PRESENTED EXTRAVASATION AND LIMB EDEMA. CATHETER RUPTURE.

  Patient problems: Extravasation; Swelling

  MAUDE report 8607377 ↗
• MalfunctionMay 8, 2019Leak/Splash; Leak/Splash

  WHILE DRAWING BLOOD/ASPIRATING FROM ONE LUMEN, BLOOD APPEARED IN THE OTHER LUMEN. POSSIBLE HOLE BETWEEN LUMENS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8591335 ↗
• MalfunctionMay 7, 2019Leak/Splash; Leak/Splash

  WHEN THE CATHETER WAS FLUSHED, THE LINE WAS LEAKING AT THE INSERTION SITE. IT APPEARS THAT THE LUMEN HAD BURST. CATHETER WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8587014 ↗
• MalfunctionJan 23, 2019Break; Break

  COMPLETE CATHETER BREAKAGE AT JUNCTION OF SECUREMENT WINGS; NO PRECIPITATING FACTORS IDENTIFIED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8270274 ↗
• MalfunctionJan 23, 2019Leak/Splash; Leak/Splash

  RN UNABLE TO FLUSH WHITE LUMEN. TPA UNSUCCESSFUL TO CLEAR LINE. NEW PICC PLACED AND WHEN OLD PICC LINE DISCONTINUED THERE WAS A HOLE IN THE LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8270103 ↗
• MalfunctionJan 23, 2019Leak/Splash; Leak/Splash

  PICC LOCATED ON RIGHT UPPER ARM. SWELLING NOTED TO ARM, ULTRASOUND PERFORMED ON (B)(6) 2018 THAT WAS NEGATIVE FOR CLOT FORMATION @ PICC SITE. ON (B)(6) 2018 PICC LINE DISCONTINUED AND FOUND TO HAVE HOLE IN IT.

  Patient problems: Swelling

  MAUDE report 8270083 ↗
• InjuryOct 25, 2018Leak/Splash; Leak/Splash

  "ON FRIDAY NIGHT, (B)(6) 2018, THE CICU REQUESTED A DOUBLE LUMEN PICC LINE PLACEMENT FOR A PATIENT. THE LINE WAS PLACED AND THE PATIENT WAS SENT BACK TO THEIR ROOM WITH A MODERATE BUT ACCEPTABLE AMOUNT OF POST PROCEDURE BLEEDING. ON MONDAY, (B)(6) 2018, THE CICU CONTACTED IR REPORTING THAT THE BLEEDING HAD WORSENED AFTER USING TPA IN THE LINE AND THAT AN EXCESSIVE AMOUNT OF BLOOD HAD BEEN LOST. IT WAS ALSO REPORTED THAT WHENEVER MAINTENANCE FLUIDS WERE GIVEN, LEAKING AROUND THE ACCESS SITE WOULD OCCURRED. FROM THE DESCRIPTION OF THE PROBLEM IR CONCLUDED THAT THE LINE MIGHT BE DEFECTIVE. THE PATIENT WAS BROUGHT BACK DOWN TO IR WHERE THE LINE WAS REPLACED. UPON EVALUATING THE LINE WHICH HAD BEEN REMOVED, A HOLE WITHIN 1 CM OF THE HUB WAS NOTICEABLE. THE LINE WAS SAVED, LABELED, AND PACKAGED TO SEND TO CLINICAL ENGINEERING."

  Patient problems: Blood Loss

  MAUDE report 8004528 ↗
• MalfunctionAug 6, 2018Break; Break

  CATHETER WAS PLACED IN PATIENT ON (B)(6) 2018. DISCOVERED ON (B)(6) 2018 THAT CATHETER HAD BROKEN AT HUB. EMAIL STATED THAT THE "CRACK LIKELY COULD BE RELATED TO INAPPROPRIATE CARE/MAINTENANCE AFTER BLOOD TRANSFUSION" NO PATIENT INJURY. CATHETER WAS PULLED AND REPLACED THE CATHETER WITH ANOTHER VASCU PICC ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7751653 ↗
• MalfunctionMay 3, 2018Leak/Splash; Leak/Splash

  CATHETER WAS TRIMMED TO 23CM AND SUCCESSFULLY INSERTED IN RIGHT BASILICA VEIN. TWO WEEKS LATER WHEN TRYING TO FLUSH THE WHITE LUER A LITTLE RESISTANCE WAS MET. UPON FURTHER INVESTIGATION THE DRESSING SITE WAS COMPLETELY WET FROM FLUSHING ATTEMPTS. THE DECISION WAS MADE BY A FELLOW TO CAP OFF THE WHITE LUER AND ATTEMPT TO USE THE RED LUER. EVENTUALLY THE SAME EFFECT OCCURRED ON THE RED LUER. THE LINE WAS REMOVED AND UPON INSPECTION OF THE LINE IT SEEMED TO BE LEAKING WHERE THE LUERS AND THE TUBING CONNECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7482775 ↗
• MalfunctionMay 2, 2018Break; Break

  LUMEN BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7479273 ↗
• MalfunctionMay 2, 2018Break; Break

  LUMEN BROKE-LU ARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7479112 ↗
• MalfunctionApr 24, 2018Break; Break

  LUMEN BROKE-RU ARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7453551 ↗
• InjuryFeb 8, 2018Break; Break

  THE TEAM WAS CONCERNED ABOUT PATIENT DISCOMFORT WHEN THE PICC LINE WAS MANUALLY FLUSHED. ONE OF THE LUMENS HAD NO BLOOD RETURN. CHEST X-RAY DEMONSTRATED A DISTINCT AREA OF DISCONTINUATION IN THE REGION OF THE LEFT AXILLA-WHICH WAS SWOLLEN. THE DECISION WAS MADE TO REMOVE THE LINE, BUT NOT AT THE BEDSIDE. IN THE OR THE SURGEON PULLED OUT THE PICC LINE UNDER FLUOROSCOPY TO THE POINT OF THE DISCONTINUATION WHICH REVEALED A FRACTURE. THERE WERE SEVERAL CM OF INTACT PICC LINE STILL IN THE VEIN. THE FRACTURED PORTION OF THE LINE WAS CUT OFF AND THREADED WITH A 0.014 GUIDEWIRE THROUGH THE PORTION OF THE PICC THAT REMAINED IN THE VEIN. USING THE GUIDEWIRE THE REMAINING PORTION OF THE LINE WAS REMOVED AND WAS DETERMINED TO BE INTACT. WITH THE GUIDEWIRE IN PLACE A NEW PICC WAS CUT TO THE PROPER LENGTH AND PASSED OVER THE GUIDEWIRE. IT DREW AND FLUSHED. FLUOROSCOPY CONFIRMED GOOD POSITION. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Swelling

  MAUDE report 7251688 ↗
• MalfunctionOct 25, 2017Leak/Splash; Leak/Splash

  CATHETER DEVELOPED LEAKING IN ONE OF THE LUMENS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976672 ↗
• MalfunctionOct 11, 2017Leak/Splash; Leak/Splash

  PICC LINE SPLIT IN THE CATHETER 1.5 CM FROM THE INSERTION POINT. IT WAS NOTED WHEN IT WAS REMOVED. PATIENT HAD ACTED THOUGH IT HURT THEN THE PICC WAS FLUSHED OVERNIGHT AND PRIOR TO REMOVAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6940131 ↗
• InjuryAug 15, 2017Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  THE PICC WAS IN THE PATIENT FOR ABOUT THREE DAYS WITH TPN RUNNING THROUGH IT. THE NURSE TOLD IR THAT THE LINE INFILTRATED.

  Patient problems: Infiltration into Tissue

  MAUDE report 6793737 ↗
• InjuryApr 20, 2017Fracture; Kinked; Leak/Splash; Occlusion Within Device; Leak/Splash

  CATHETER OCCLUSION-T-PA INSTILLED AND DWELLED FOR 90 MIN. PATENCY RESTORED. IV FLUIDS RESTARTED. THREE HOURS LATER PATIENT HAS LEG SWELLING AND REPEAT CATHETER OCCLUSION. DRESSING REMOVED AND KINK IN THE CATHETER WAS DISCOVERED. ONCE UNKINKED THE CATHETER FLUSHED EASILY. LEAKING NOTED AT INSERTION SITE WHEN FLUSHED. PICC REMOVED AND A FRACTURE WAS NOTED (EXTERNAL CATHETER LENGTH 6CM, FRACTURE AT 8CM).

  Patient problems: No Known Impact Or Consequence To Patient; Swelling

  MAUDE report 6508492 ↗
• MalfunctionMar 2, 2017Occlusion Within Device; Material Protrusion/Extrusion; Torn Material

  THE CENTRAL VENOUS CATHETER WAS NOTED TO BE OCCLUDED AND BULGING APPROXIMATELY 2 MONTHS AFTER INSERTION. UPON REMOVAL, A TEAR WAS NOTED AT THE 4 CM MARK.

  Patient problems: No Information

  MAUDE report 6371576 ↗