PowerPICC SOLO2 Catheter 3295335Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741028120), received between Mar 23, 2017 and Jul 22, 2025 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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.

• MalfunctionJul 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT CAME INTO THE PICC CLINIC WITH A DOUBLE LUMEN PICC THAT WAS OVER 1 YEAR OLD. SHE HAD IR INSERT THIS PICC DUE TO HER DIFFICULT VASCULATURE AND SHE STATED THAT THEY HAD DIFFICULTY. THE PATIENT FOUND HER TPN WAS LEAKING FROM THE OPPOSITE LUMEN BEING USED FOR THE INFUSION. SHE THOUGHT THERE WAS A HOLE IN THE PICC, WHICH WAS WHY SHE ASKED FOR HER MEDICAL TEAM TO HAVE THE PICC REMOVED AND A NEW ONE PLACED. THIS 5 FR DOUBLE LUMEN PICC WAS REMOVED EASILY AND NO DEFECTS WERE OBSERVED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572257 ↗
• MalfunctionJun 24, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED, PATIENT HAS PICC PLACED ON (B)(6) 2025 AND SINCE THE PICC WAS PLACED, IT HAD MULTIPLE ISSUES. IT FREQUENTLY BLOCKED, WAS TPA MULTIPLE TIMES AND NEEDED HEPARIN TO MAINTAIN. IT WAS VERY POSITIONAL. THEN FINALLY AFTER MONTHS OF BEING NOTHING BUT TROUBLE AND NEEDED TO REPLACE IT. IT WAS REMOVED (B)(6) 2025. ADDITIONAL INFO / IMPACT OF INCIDENT: PATIENT REQUIRED NEW PICC ¿ PROLONGED CARE. NO INVASIVE PROCEDURE REQUIRED. ADDITIONAL INFORMATION PROVIDED: PATIENT REQUIRED FREQUENT APPLICATION OF TPA HEPARIN (CLINIC VISITS) TO MAINTAIN PATENCY THEN ULTIMATELY REQUIRED REPLACEMENT. THIS PICC WAS PLACED AS THE PATIENT IS A DIFFICULT BLOOD DRAW. WE WOULD HAVE TO MOVE THE PATIENTS ARM AND GET HER TO COUGH ETC. AND STILL NO BLOOD RETURN. SOMETIMES BATHING HER WOULD HELP GET IT WORKING. PICC SHOULD JUST BE MAINTAINED BY NORMAL SALINE AND WE OFTEN MUST USE HEPARIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325045 ↗
• MalfunctionMar 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED UPON FLUSHING THE PICC NOTICED THERE WAS A HOLE IN THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649540 ↗
• InjuryJul 18, 2024Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED, "BARD POWER PICC LINE CAUSED AN ISSUE WITH A PATIENT DURING INSERTION. THE TECHNOLOGIST INVOLVED REPORTED THE INCIDENT OCCURRED (B)(6). PATIENT WAS BROUGHT DOWN TO INTERVENTIONAL RADIOLOGY FOR A PICC LINE. DURING THE PROCESS OF ATTEMPTING TO ACCESS A SUITABLE VEIN AND INTRODUCE A GUIDE WIRE, THE WIRE FAILED AND THE TIP UNCOILED. AS A RESULT, THE WIRE WAS CAUGHT IN THE PATIENTS ARM. ATTEMPTS WERE MADE TO REMOVE THE WIRE, ONCE THE WIRE WAS REMOVED FROM THE PATIENTS ARM, FLUOROSCOPY WAS USED AND SHOWED A SMALL PIECE OF METAL WAS STILL IN THE PATIENTS SKIN. RADIOLOGIST TALKED TO ON CALL VASCULAR SURGEON, MORE TESTS BEING ORDERED TO DETERMINE IF ADDITIONAL INTERVENTION IS REQUIRED. PATIENT AWARE OF THE POSSIBILITY OF FOREIGN OBJECT IN ARM. THE PATIENT HAD FURTHER IMAGING BY CT AND ULTRASOUND TO DETERMINE THE LOCATION OF THE FOREIGN BODY. IT WILL THEN BE DISCUSSED IF THE PATIENT WILL UNDERGO SURGERY TO REMOVE THE FOREIGN BODY. CT & US SHOWS THE FOREIGN BODY IN THE SOFT TISSUE." ADDITIONAL INFORMATION RECEIVED 2 JULY 2024: A SMALL PIECE OF THE METALLIC DISTAL TIP OF THE ADVANCING WIRE BECAME STUCK JUST BELOW THE SKIN SURFACE AT THE LEVEL OF THE BRACHIAL VEIN OVERLYING THE

  Patient problems: Foreign Body In Patient

  MAUDE report 19777877 ↗
• MalfunctionMay 23, 2024Backflow; Failure to Infuse; Backflow; Failure to Infuse

  IT WAS REPORTED THAT PURPLE VALVE DID NOT WORK. HAD TO EXCHANGE FOR NEW PICC. THERE WAS NO DAMAGE TO THE VALVE. IT TOOK EXTRA TIME FROM THE PATIENT TO REPLACE THE PRODUCT. THERE WAS AN INTERRUPTION OR DELAY IN MEDICATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388661 ↗
• MalfunctionJul 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED "WE HAD A SHEATH IN MAY THAT THE TIP ON IT BECAME JAGGED UPON USE." NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144178 ↗
• MalfunctionJul 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED SHEATH TIP BECAME JAGGED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140031 ↗
• MalfunctionMar 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PICC INSERTED ON (B)(6) 2021 HAD TO BE REPLACED DUE TO A HOLE IN THE CATHETER. IT WAS FURTHER REPORTED THAT THE HOLE IS LOCATED CLOSE TO THE END WHERE IT BUTTERFLIES TO THE SKIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11477759 ↗
• MalfunctionFeb 22, 2021Material Deformation; Unraveled Material; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE THE GUIDE WIRE CAME OFF AND UNRAVELLED. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 11361742 ↗
• MalfunctionFeb 19, 2021Unraveled Material; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, THREE (3) PICCS WERE USED DUE TO THE GUIDEWIRE CONSTANTLY KINKING, NOT BEING ABLE TO THREAD THROUGH THE VEIN, AND ONE WIRE CAME OFF AND UNRAVELLED. THIS REPORT ADDRESSES THE SECOND DEVICE.

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

  MAUDE report 11349390 ↗
• MalfunctionFeb 19, 2021Material Deformation; Unraveled Material; Failure to Advance; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE, THREE (3) PICCS WERE USED DUE TO THE GUIDEWIRE CONSTANTLY KINKING, NOT BEING ABLE TO THREAD THROUGH THE VEIN, AND ONE WIRE CAME OFF AND UNRAVELLED. THIS REPORT ADDRESSES THE FIRST DEVICE.

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

  MAUDE report 11349388 ↗
• MalfunctionFeb 19, 2021Unraveled Material; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE, THREE (3) PICCS WERE USED DUE TO THE GUIDEWIRE CONSTANTLY KINKING, NOT BEING ABLE TO THREAD THROUGH THE VEIN, AND ONE WIRE CAME OFF AND UNRAVELLED. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11349383 ↗
• MalfunctionSep 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER PLACED THE CATHETER INTO PATIENT, THEY TRIED TO FLUSH IT AND FOUND THAT WHEN THEY PUSHED SALINE INTO PURPLE PORT, SOME BLOOD WAS FLOW OUT FROM RED PORT. THEY FLUSHED THE RED PORT SEVERAL TIME BUT STILL SAME PROBLEM. DOCTOR REPLACED A NEW CATHETER TO COMPLETE THE SURGERY, REPLACEMENT FINALLY OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10574486 ↗
• MalfunctionSep 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER PLACED THE CATHETER INTO PATIENT, THEY TRIED TO FLUSH IT AND FOUND THAT WHEN THEY PUSHED SALINE INTO PURPLE PORT, SOME BLOOD WAS FLOW OUT FROM RED PORT. THEY FLUSHED THE RED PORT SEVERAL TIME BUT STILL SAME PROBLEM. DOCTOR REPLACED A NEW CATHETER TO COMPLETE THE SURGERY, REPLACEMENT FINALLY OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10574334 ↗
• MalfunctionJul 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOME CARE OFFICE AND WAS SEEN IN THE TREATMENT ROOM FOR ROUTINE DRESSING CHANGE OF A PICC SITE. LPN PROVIDING THE CARE REMOVED THE OLD DRESSING AND PROCEEDED TO CLEAN THE SITE. WHEN SLIGHTLY REPOSITIONING THE PICC LINE, THE LPN NOTICED THERE WAS A CRACK AND THE CLIENT WAS SLOWLY OOZING SANGUINEOUS FLUID FROM THE CRACK IN THE LINE. IT WAS STATED THE LOCATION OF THE CRACK IS ON THE RED LUMEN LINE OF THE PICC LINE. LPN FINISHED CLEANING THE SITE, PUT A DRESSING ON THE SITE AND SENT CLIENT TO THE NEAREST HOSPITAL THAT COULD ASSESS THE PICC AND REINSERT A NEW LINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10254724 ↗
• MalfunctionApr 28, 2020Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE PEEL AWAY PORTION OF THE INTRODUCER WAS STUCK, RENDERING IT INEFFECTIVE AND A SEPARATE INTRODUCER WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10005973 ↗
• MalfunctionDec 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER PLACED THE CATHETER INTO PATIENT, THEY TRIED TO FLUSH IT AND FOUND THAT WHEN THEY PUSHED SALINE INTO PURPLE PORT, SOME SALINE WAS FLOW OUT FROM RED PORT WHILE PUSHING THE SALINE IN. DOCTOR REPLACED A NEW CATHETER TO COMPLETE THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9496230 ↗
• MalfunctionSep 3, 2019Difficult to Flush; Component Missing

  IT WAS REPORTED THAT DURING A CALL TO MS&S, THE NURSE STATED SHE WAS UNABLE TO FLUSH OR OBTAIN A BLOOD RETURN FROM POWERPICC SOLO (3295335, REDP3063) SO SHE REMOVED IT. SHE NOTICED THAT IT DID NOT HAVE THE BLACK TIP AS SHE IS USED TO AND WANTED TO MAKE SURE THAT A PIECE HAD NOT BEEN LEFT BEHIND. SHE STATES THE PICC IS THE SAME LENGTH AS WHEN IT WAS INSERTED. MS&S RESPONSE: DISCUSSED POSSIBLE CAUSES OF OCCLUSIONS. INFORMED THAT THE POWERPICC SOLO IS A VALVED CATHETER WITH THE VALVES IN THE HUB. THIS PICC CAN BE TRIMMED ON THE END. EXPLAINED THAT THE POWERGROSHONG PICC IS A VALVED CATHETER WITH A BLACK TIP. HOWEVER, THE VALVE IS ON THE TIP DISTAL TIP OF THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8956091 ↗
• MalfunctionAug 22, 2018Complete Blockage

  IT WAS REPORTED THAT THE RED PORT WAS BLOCKED ON (B)(6) 2018 WHEN SEEN BY NURSE AT 10. PATIENT SENT TO ER FOR ALTEPLASE AND AFTER FIRST ALTERPLASE ATTEMPT, PICC ALLEGEDLY REMAINED BLOCKED DELAYING (B)(6) VANCOMYCIN DOSE TO BE GIVEN AT 22:00. IT WAS STATED THE PICC REMAINED BLOCKED (B)(6), SO CLIENT HAD TO RECEIVE MEDS PERIPHERALLY IN ER ON ALTERED DOSE SCHEDULE. THE SECOND ATTEMPT IN ER ALTERPLAS AT 10:00 (B)(6) WAS SUCCESSFUL IN UNBLOCKING RED PORT.

  MAUDE report 7807778 ↗
• MalfunctionMay 17, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THERE WAS CONTINUOUS BLEED BACK FROM THE PURPLE LUMEN AFTER PLACEMENT. THEY PERFORMED AN OVER-THE-WIRE REPLACEMENT AND INSERTED A NEW CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7522378 ↗
• MalfunctionMar 16, 2018Adverse Event Without Identified Device or Use Problem

  PATIENT CALLED REPORTING THAT HER LEFT HAND AND ENTIRE LEFT ARM ARE BOTH SWOLLEN AND PAINFUL. THREE DAYS EARLIER AN INTERVENTIONAL RADIOLOGIST PLACED A POWERPICC SOLO PICC LINE FOR ADMINISTRATION OF TPN. MS&S ADVISED HER TO SEE HER DOCTOR AS SOON AS POSSIBLE.

  Patient problems: Pain; Swelling

  MAUDE report 7346913 ↗
• MalfunctionFeb 13, 2018Kinked

  IT WAS REPORTED THAT THE WIRES HAD A SMALL KINK IN THEM JUST WHERE THE TIP BECOMES FLOPPY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7268672 ↗
• MalfunctionNov 15, 2017Occlusion Within Device; Physical Resistance

  IT WAS REPORTED THAT PATIENT CAME INTO CLINIC TO RECEIVE A PUSH IV ANTIBIOTIC (CEFTRIAXONE) AND A HPT BAG CHANGE (VANCOMYCIN). THE RED PORT OF THE PICC WAS ALLEGEDLY OCCLUDED AND ONLY THE PURPLE PORT WAS BEING USED. NURSE STOPPED THE HPT PUMP, DISCONNECTED AND CAPPED THE HPT LINE. THE PURPLE PORT WAS DISINFECTED AND FLUSHED AGAIN. IT WAS STATED IT FLUSHED WITH A GREAT DEAL OF RESISTANCE, SO THE NURSE STOPPED FLUSHING. NURSE TRIED TO ASPIRATE FOR BLOOD RETURN AND THERE WAS NO FLASHBACK. PATIENT COULD NOT RECEIVE EITHER OF THE TWO ANTIBIOTICS. PATIENT WAS SENT TO FAMILY DOCTOR AND THEN TO EMERGENCY DEPARTMENT TO RECEIVE TPA. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7033363 ↗
• InjurySep 7, 2017Bent; Break; Detachment Of Device Component; Material Frayed

  IT WAS REPORTED BY THE INTERVENTIONAL RADIOLOGY PHYSICIAN THAT THE PICC GUIDEWIRE FRAYED AND BROKE OFF INSIDE THE PATIENT. THEY WERE ABLE TO SNARE THE WIRE OUT. IT WAS NOTED THAT THE PATIENT WAS GREATLY SCLEROSED AND WAS METING RESISTANCE. THE PHYSICIAN WENT THROUGH THE DILATOR AND SHEATH 3-4 TIMES AND STATED THE TIP OF THE DILATOR WAS BENT. SINCE THE TIP WAS BENT THE PHYSICIAN ALLEGES THIS MAY HAVE CAUSED THE WIRE TO FRAY, GET CAUGHT ON THE DILATOR AND BREAK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6850042 ↗
• MalfunctionMar 23, 2017Malposition of Device; Aspiration Issue

  FACILITY REPORTED TO THE SALES REP THAT THEY ARE UNABLE TO ASPIRATE. NO OTHER INFORMATION HAS BEEN REPORTED, BUT HAS BEEN REQUESTED. RECEIVED 3/13/17 - ADDITIONAL INFORMATION REPORTED BY THE FACILITY. THE PICC WAS PLACED BY THE PICC TEAM AND STATED "IT HAD FLOATED UP", X-RAY INDICATED INCORRECT PLACEMENT. PICC WAS REMOVED. THE HEALTHCARE PROFESSIONAL WAS NOT CERTAIN IF THE INITIAL PICC WAS FLUSHED, PRIOR TO REMOVAL. A NEW DEVICE WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6429852 ↗