PowerPICC SOLO2 Catheter 3194335Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741027772), received between Oct 25, 2016 and Nov 12, 2025 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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. Mar 11, 2025Class IOpen, Classified

   Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

   Z-1507-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WE HAD A PATIENT WITH A LEAKING PICC LINE. UPON FLUSHING OF THE PICC, IT WAS NOTICED THAT IT WAS LEAKING FROM THE EXTERNAL PART OF THE PICC LINE (BELOW THE BUTTERFLY). THE PICC WAS REMOVED. AFTER REMOVAL, THE PICC LINE WAS FURTHER INSPECTED, AND IT WAS NOTED THAT THERE WAS A HOLE AT THE 19CM MARK ON THE PICC LINE. NO PATIENT HARM AS PICC WAS REMOVED BEFORE TREATMENT WAS GIVEN. CATHETER WAS SECURED WITH 3M TEGADERM IV ADVANCED SECUREMENT DRESSING. PATIENT IS GETTING A NEW PICC INSERTED ON NOVEMBER 14. NO DELAY IN TREATMENT, PATIENT RECEIVED TREATMENT THROUGH PERIPHERAL IV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534546 ↗
• InjurySep 26, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED BY CUSTOMER THAT A SL PICC LINE ON AN INPATIENT TODAY, AND THE PEEL AWAY SHEATH BROKE AT THE HUB AND LITERALLY VACUUMED INTO THE PATIENT'S VEIN . IT TOOK THE RADIOLOGIST AWHILE AND DIFFICULTIES TO TRY TO SNARE THIS OUT OF THE PATIENT'S VEIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 17819731 ↗
• MalfunctionJun 22, 2023Backflow; Backflow

  IT WAS REPORTED BY THE CUSTOMER THAT BLOOD WAS FLOWING OUT OF PICC LINE HUB DURING ROUTINE WEEKLY CAP AND DRESSING CHANGE. PICC IS A VALVED LINE WITH NO EXTERNAL CLAMP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17184326 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MS&S "CALLER STATES SHE HAS POWERPICC SOLO 3194335. CALLER ASKING WHAT THE PICC LINE IS USED FOR AND WHERE IT SHOULD BE PLACED. HOW LONG WILL IT STAY IN? CALLER STATES SHE IS IN THE HOSPITAL RIGHT NOW AND THEY DID NOT GIVE HER TOO MUCH INFORMATION. DOES IT CAUSE BLOOD CLOTS? CALLER ASKING IF SHE NEEDS TO TAKE MEDICATION TO KEEP FROM GETTING BLOOD CLOTS NOW THAT SHE HAS A PICC LINE. HOW DO I KNOW I'M NOT "REJECTING" THE PICC? CALLER STATES THE PICC (3194335, LOT # REFS0777). MS&S EXPLAINED THAT THE POWERPICC IS USED TO GIVE IV MEDICATION, IV FLUIDS AND FOR BLOOD DRAWS. EXPLAINED THERE IS NO SET DWELL TIME FOR PICCS AND THAT HER DOCTOR WILL NEED TO DECIDE WHEN THE PICC SHOULD COME OUT BASED ON CLINICAL INDICATIONS. EXPLAINED THAT WE DO NOT HAVE A RECOMMENDATION FOR TAKING A MEDICATION TO PREVENT BLOOD CLOTS. PICCS DO NOT CAUSE BLOOD CLOTS BUT PATIENTS CAN ACQUIRE A CLOT IN OR NEAR THE PICC ITSELF. HER DOCTOR WILL NEED TO MONITOR HER CLOSELY AND PROVIDE INTERVENTIONS TO PREVENT BLOOD CLOTS WHILE IN THE HOSPITAL. CALLER STATES SHE IS HAVING SORENESS AND SHORTNESS OF BREATH AND THE DOCTOR'S ARE "DISMISSING" HER NOW. EXPLAINED THAT IF SHE IS ALLERGIC TO THE MATERIALS

  Patient problems: Dyspnea; Pain

  MAUDE report 12626026 ↗
• MalfunctionAug 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA (B)(6) MEDICAL DEVICES ONLINE DATABASE: "F26 - NO HEALTH CONSEQUENCES OR IMPACTE2401 - INSUFFICIENT INFORMATIONF24 - INSUFFICIENT INFORMATIONA26 - INSUFFICIENT INFORMATIONA041001 - MATERIAL PUNCTURE / HOLE." NO OTHER INFORMATION REGARDING THE EVENT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309796 ↗
• MalfunctionAug 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA HEALTH (B)(6) MEDICAL DEVICES ONLINE DATABASE. (B)(4). NO OTHER INFORMATION REGARDING THE EVENT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309269 ↗
• MalfunctionJul 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN IRRIGATING THE PICC LINE OF A PATIENT WITH A 10ML SYRINGE, THERE WAS A LEAK OF ABOUT 3CC AT THE INSERTION SITE. THE PATIENT WAS SEEN BY A CHEMOTHERAPY NURSE WHO OBSERVED THE PROBLEM. BEING IN HER LAST TREATMENT, THE CHEMO NURSE PROCEEDED TO WITHDRAW THE PICC LINE. A PERIPHERAL VENOUS LINE WAS INSTALLED FOR ITS TREATMENT. DURING THE WITHDRAWAL THE NURSE TOLD US THAT SHE FELT A SLIGHT RESISTANCE AND NOTICED THAT THE CATHETER WAS PRACTICALLY CUT A / N OF THE 17TH CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127516 ↗
• MalfunctionDec 3, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT A NURSE NOTED THAT THE PATIENT'S PICC LINE DRESSING WAS STAINED WITH YELLOW COLOURED DRAINAGE, AND THE PATIENT WAS TAKEN TO THE HOSPITAL TO ASSESS. THE PICC WAS FLUSHED AND NO ACTIVE LEAK WAS NOTED; HOWEVER, AFTER THE DEVICE WAS REMOVED, THE PICC WAS FLUSHED AGAIN AND A GRADUAL LEAK AT THE HUB WHICH IS LOCATED NEAR TO THE WING WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10942624 ↗
• MalfunctionOct 16, 2020Material Puncture/Hole

  IT WAS REPORTED THAT THE POWERPICC SOLO PRESENTED A HOLE JUST BELOW THE SECUREMENT WING. THE CATHETER HAD TO BE REMOVED AFTER BEING INSTALLED ON (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10692091 ↗
• MalfunctionSep 10, 2020Failure to Infuse; Failure to Infuse

  IT WAS REPORTED VIA MS&S "CALLER PLACES A LOT OF POWERPICC SOLO CATHETERS. LAST WEEK THEY PLACED A POWERPICC SOLO IN A PATIENT AND SENT THE PATIENT BACK TO THE NURSING HOME. THE PICC OCCLUDED IMMEDIATELY AND HAD TO BE REPLACED AND THE SECOND SOLO PICC ALSO OCCLUDED. HE IS WONDERING IF THEY CAN LOCK THE SOLO WITH SOME HEPARIN? BOTH WERE PRODUCT CODES 3194335 LOT NUMBER REER0510." MS&S RESPONDED "CONFIRMED THAT HEPARIN MAY BE NEEDED IN SOME PATIENTS AND IS NOT CONTRAINDICATED. THEY USE THE NEUTRON NEEDLELESS CONNECTOR". THIS REPORT ADDRESSES THE SECOND PICC THAT OCCLUDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10518592 ↗
• MalfunctionSep 10, 2020Failure to Infuse; Failure to Infuse

  IT WAS REPORTED VIA MS&S "CALLER PLACES A LOT OF POWERPICC SOLO CATHETERS. LAST WEEK THEY PLACED A POWERPICC SOLO IN A PATIENT AND SENT THE PATIENT BACK TO THE NURSING HOME. THE PICC OCCLUDED IMMEDIATELY AND HAD TO BE REPLACED AND THE SECOND SOLO PICC ALSO OCCLUDED. HE IS WONDERING IF THEY CAN LOCK THE SOLO WITH SOME HEPARIN? BOTH WERE PRODUCT CODES 3194335 LOT NUMBER REER0510." MS&S RESPONDED "CONFIRMED THAT HEPARIN MAY BE NEEDED IN SOME PATIENTS AND IS NOT CONTRAINDICATED. THEY USE THE NEUTRON NEEDLELESS CONNECTOR". THIS REPORT ADDRESSES THE FIRST PICC THAT OCCLUDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10518508 ↗
• MalfunctionApr 9, 2019Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PICC WAS INITIALLY INSERTED ON THE (B)(6) 2018 AND WAS FOUND TO BE LEAKING ON THE (B)(6) 2019. THE PICC WAS REMOVED AND HAD A SPLIT IN IT.

  Patient problems: No Information

  MAUDE report 8496096 ↗
• MalfunctionSep 5, 2018Difficult to Open or Close

  IT WAS REPORTED THAT WHEN CHANGING THE CAP OF THE PICC LINE WITH VALVE, A SEROLOGICAL (HUMAN FLUID) RETURN OF BLOOD WAS NOTED DROP BY DROP. IT WAS STATED THE VALVE INSIDE THE PICC LINE DID NOT SEEM TO CLOSE. IN THE ICU, THE NEUTRAL PRESSURE PROCEDURE WAS APPLIED DURING THE IRRIGATION OF THE PICC LINE, WHICH WANTS TO KEEP THE PLUNGER DEPRESSED FOR A FEW SECONDS TO RETURN THE VALVE. THE ADMINISTRATION OF THE ANTIBIOTIC THERAPY WAS COMPLETED. PATIENT WAS NOT INJURED AND PICC LINE REMOVED FOR ANOTHER UNKNOWN MEDICAL REASON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7848032 ↗
• MalfunctionMay 23, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT A NURSE CALLED INTO THE MS&S HELPLINE. NURSE STATES THAT HER PATIENT GOT POWERPICC SOLO INSERTED ON 5/1 AND SHE STATES WHEN THE PATIENT CROSS HER ARMS TOGETHER SHE EXPERIENCES PALPITATIONS AND THEY GO AWAY WITH THE UNCROSSING OF THE ARMS. SHE IS ASKING IF THAT IS NORMAL. RESPONSE BY MS&S: INFORMED THAT NURSE THAT SHE SHOULD CONTACT HER PHYSICIAN AND ASK ABOUT PERFORMING A CHEST X-RAY IN THE POSITION WHERE THE PALPITATIONS OCCUR. MS&S INFORMED THAT THE PICC TIP DOES CHANGE POSITIONS WITH CERTAIN MOVEMENTS AND POSITION CHANGES.

  Patient problems: Palpitations

  MAUDE report 7539190 ↗
• 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 Information

  MAUDE report 7268664 ↗
• MalfunctionDec 29, 2017Packaging Problem

  IT WAS REPORTED ON 12/8/2017, THAT THE PICC WAS SEALED IN THE SEAL OF THE PACKAGING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7154434 ↗
• InjuryMar 30, 2017Break; Difficult to Remove

  IT WAS REPORTED THAT WHEN THE GUIDEWIRE WAS INTRODUCED INTO THE RIGHT BASILIC VEIN AND ADVANCED TO THE DISTAL SVC AND THEN THE DILATOR WAS INTRODUCED. THE PICC CATHETER WAS FED INTO THE SHEATH AND THE PATIENT BEGAN EXPERIENCING DISCOMFORT. FLUOROSCOPY REVEALED THAT THE WIRE WAS BROKEN AT THE JUNCTION WHERE TIP OF DILATOR MEETS THE WIRE. THE GUIDEWIRE AND SHEATH WERE REMOVED. THE BROKEN PIECE OF GUIDEWIRE REMAINED IN THE PATIENT (RIGHT BASILICA -> RIGHT SUBCLAVIAN). PATIENT WAS TAKEN TO THE OR AND SURGERY WAS REQUIRED BY A VASCULAR SURGEON TO REMOVE THE BROKEN PIECES OF THE GUIDE WIRE. PATIENT WAS KEPT OVERNIGHT AND DISCHARGED ON (B)(6) 2017.

  Patient problems: Discomfort

  MAUDE report 6446425 ↗
• InjuryOct 25, 2016Break; Detachment Of Device Component; Migration or Expulsion of Device

  ON (B)(6) 2016 - FACILITY REPORTED TO THE SALES REPRESENTATIVE THAT WHEN PLACING A PICC THE HEALTHCARE PROFESSIONAL STATED THE ORANGE CLIPS BROKE OFF AND THE SHEATH MIGRATED TO THE PATIENT'S GROIN. NO OTHER INFORMATION PROVIDED. ON (B)(6) 2016 - FACILITY REPORTED ADDITIONAL INFORMATION TO THE SALES REPRESENTATIVE REGARDING THIS EVENT. DURING PICC PLACEMENT INTO THE LEFT MEDIAL BRACHIAL, BOTH OF THE ORANGE CLASPS BROKE OFF, CAUSING THE SHEATH TO MIGRATE TO THE PATIENTS GROIN. THIS WAS CONFIRMED BY CT SCAN. FACILITY STATED THAT THE SHEATH DID NOT PEEL AWAY AT ALL. THE PIECE THAT MIGRATED WAS 10CM. THE SHEATH RETRIEVED VIA FEMORAL APPROACH AND RETRIEVED BY SNARE. ON (B)(6) 2016 - SALES REPRESENTATIVE CONFIRMED WITH THE FACILITY THAT THE CATHETER INSERTION WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 6056072 ↗