PowerPICC SOLO2 Catheter 3194118Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741027741), received between Dec 4, 2015 and Jun 23, 2025 — classified as 1 injury, 9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED; PATIENT WAS SCHEDULED FOR A PICC DRESSING CHANGE ON (B)(6) (6 DAYS FROM HIS PREVIOUS AS PODS CLOSED FRIDAY (B)(6). PATIENT'S MOM CALLED PODS (B)(6) TO CANCEL DRESSING CHANGE AS FAMILY GOING CAMPING, REBOOKED FOR MONDAY (B)(6). PATIENT ARRIVED TO PODS (B)(6) AT 1400 FOR PICC DRESSING CHANGE. PATIENT'S MOM STATED PATIENT HAD BEEN "IRRITABLE" AND REQUESTING BLOODWORK. PATIENT AFEBRILE AT 36.5. WRITER CONTACTED PEDS ON CALL DR. FOR BW ORDERS. PATIENT'S MOM STATED OLD SANG TO PICC TUBING. NOTED LARGE AMOUNT OF OLD SANG IN PICC TUBING. ATTACHED SALINE FLUSH, OPENED PICC CLAMP AND ASPIRATED BLOOD INTO A SALINE FLUSH. BRISK BLOOD RETURN NOTED. ATTACHED VACUTAINER FOR BLOOD SAMPLE BUT NOTED VACUTAINER DID NOT WORK AND TUBES WOULD NOT FILL. AROUND SAME TIME, STARTED TO NOTICE DROPS OF BLOOD ON THE TOWEL UNDER PATIENTS PICC ARM, NEAR THE PICC CLAMP. USED A CHLORHEXIDINE SWAB TO TOUCH AROUND THE PICC CLAMP, AND CHLORHEXIDINE SWAB WAS STAINED WITH FRESH SANG - A LEAK APPEARED TO BE AROUND EITHER THE PICC CLAMP ITSELF OR THE TUBING AROUND THE CLAMP. NOTED A STRONG INDENTATION IN THE PICC TUBING WHERE THE CLAMP MUST'VE BEEN CLAMPED. MOM STATED PATIENT AND DAD HAD BEEN PLAY WRESTL

  Patient problems: Irritability

  MAUDE report 22310415 ↗
• MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NURSING UNIT WAS CALLED AS PICC WAS ¿LEAKING¿. WHEN FLUSHED, A FLUID LEAKING WAS NOTED FROM INSERTION SITE. AFTER PICC WAS REMOVED, A ¿SLIT¿ IN CATHETER WAS NOTED AT THE 10CM MARK THAT LEAKED WHILE FLUSHING. PATIENTS PICC WAS AT 10CM EXTERNAL DURING USE AND CEPHALIC VEIN WAS USED AS PATIENT IS WHEELCHAIR BOUND. PICC WAS IN FOR 124 DAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857714 ↗
• MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC LINE WAS BROKEN/LEAKING. WHEN FLUSHED, THE PICC LINE WAS NOTED TO BE LEAKING. UNIT INSTRUCTED TO REMOVE PICC LINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857709 ↗
• MalfunctionApr 27, 2018Migration or Expulsion of Device; Occlusion Within Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PICC WAS INSERTED (B)(6) 2018. ON (B)(6) 2018, THE NURSE WAS INFUSING MEDICATION AND THE PUMP BEGAN ALARMING THAT THERE WAS AN OCCLUSION. UPON ASSESSMENT THE NURSE WAS UNABLE TO FLUSH PICC AND FOUND THAT IT WAS FULLY OCCLUDED. ¿PICC 50 CM AND EXTERNAL LENGTH = 9 CM.¿ A VASCULAR ACCESS NURSE SAW THE PATIENT IN THE MORNING OF (B)(6), 2018 FOR THE OCCLUSION. A CHEST X-RAY SHOWED THAT THE PICC TIP MIGRATED, BUT THERE WAS NO CHANGE IN EXTERNAL LENGTH. THE PICC WAS REMOVED AND A KINK WAS NOTED AT THE 18CM MARK (THAT WOULD BE INSIDE OF THE PATIENT.) NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7470514 ↗
• MalfunctionApr 26, 2018Kinked; Occlusion Within Device

  IT WAS REPORTED THAT THE PICC WAS OCCLUDED AT FIRST ATTEMPT TO USE. THE TOTAL CATHETER LENGTH WAS53 CM WITH EXTERNAL LENGTH OF 9 CM. REPORTED BY NURSING STAFF THAT TREATED WITH CATHFLO ON (B)(6) WITH NO EFFECT. CXRAY DONE WITH CHANGE IN TIP POSITION NOTED. NO CHANGE IN EXTERNAL LENGTH. PICC REMOVED AND NOTED MEMORY OF KINK AT 14CM MARK (PART THAT WAS INSIDE PATIENT).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7466752 ↗
• MalfunctionJun 22, 2017Fluid/Blood Leak

  IT WAS REPORTED ON (B)(6) 2017 THAT THERE WAS LEAKING AT THE SITE. THE DRESSINGS WERE ALSO REPORTEDLY DAMP CAUSING THE LINE TO BE EXPOSED TO POSSIBLE MIGRATION/INFECTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6659826 ↗
• MalfunctionMay 18, 2017Inadequate or Insufficient Training; Positioning Problem

  CALLER STATED THAT SHE HAS HAD MANY PICC LINES DUE TO HAVING ANEMIA FROM GASTRIC BYPASS SURGERY. SHE SAID THAT THE BIFURCATION ON THE CURRENT PICC WAS PUSHED INTO HER ARM DUE TO THE STATLOCK BEING LOCATED IN HER ELBOW CREASE. SHE STATED THAT THE FACILITY NEEDS TO BE TRAINED ON WHERE TO PLACE THE PICC SO THAT IT IS NOT LOCATED IN THE ELBOW CREASE. THE PATIENT SAID THAT HER DOCTOR PULLED THE PICC OUT AND BACK INTO POSITION. THE LINE IS STILL INSERTED. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6576028 ↗
• MalfunctionDec 16, 2016Fluid/Blood Leak; Hole In Material

  NURSE REPORTED THAT A PATIENT WAS SCHEDULED TO RECEIVE CHEMOTHERAPY TREATMENT. THE NURSE WAS UNABLE TO GET BLOOD RETURN AT INITIAL ASSESSMENT AND THE PATIENT COMPLAINED OF PAIN JUST ABOVE THE INSERTION SITE. THE PATIENT WAS SENT TO ANOTHER FACILITY FOR FURTHER ASSESSMENT AND IT WAS REPORTED THAT LEAKING WAS NOTED ESCAPING FROM THE EXIT SITE FROM THE PATIENT. NURSE REPORTED THAT THE PICC REMOVED BY 1 CM AND A HOLE WAS NOTED (HOLE FOUND IN PICC LINE AT ~ THE 7CM MARK). THE PICC WAS REMOVED. THE PATIENT MISSED THE CHEMOTHERAPY TREATMENT BUT NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6181360 ↗
• MalfunctionFeb 25, 2016Fracture; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT WAS RECEIVING A CHEMOTHERAPY MEDICATION THROUGH THE PICC WHEN THEY ALLEGEDLY EXPERIENCED BURNING AT THE PATHWAY OF THE PICC LINE STATING IT ACHED TO THE BONE. THE INFUSION WAS STOPPED. THE CHEMO AGENT WAS ALLEGEDLY SEEN LEAKING OUT OF THE PICC INSERTION SITE. THE PICC WAS REMOVED. UPON REMOVAL THERE WERE TWO ALLEGED OBVIOUS FRACTURES TO THE PICC LINE, ONE SEEN AT THE 3 1/2CM MARK AND THE SECOND AT THE 5CM MARK. THE PATIENTS ARM WAS NOTED TO BE SLIGHTLY SWOLLEN, RED AND ACHY, OBVIOUS CHEMO EXTRAVASATION.

  Patient problems: Burning Sensation; Erythema; Extravasation; Swelling

  MAUDE report 5461798 ↗
• InjuryDec 4, 2015Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD AN AREA OF NECROSIS AT PICC INSERTION SITE. AN ALLEGED LEAK WAS ASSUMED.

  Patient problems: Necrosis

  MAUDE report 5269068 ↗