PowerPICC SOLO2 Catheter 1295108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 00801741034602), received between Feb 29, 2016 and Sep 2, 2026 — classified as 15 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Expiration Date Error” (36 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. May 21, 2026Class IIOpen, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2666-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 125 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569341 ↗
• MalfunctionSep 2, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569339 ↗
• MalfunctionMay 27, 2026Unsealed Device Packaging

  IT WAS REPORTED PICC NURSE NOTICED THAT THE PICC KIT WAS RECEIVED WITH A DEFECTIVE SEAL. THE KIT WAS UNUSABLE AND HAD TO BE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303186 ↗
• MalfunctionMay 19, 2026Product Quality Problem

  IT WAS REPORTED PLACED A DOUBLE LUMEN PICC ON A PATIENT FOR DISCHARGE. WHEN I WENT TO FLUSH THE RED LUMEN DURING INSERTION, THE STOPPER HOLDING THE WIRE POPPED OFF. THIS CAUSED A FAULTY READING ON THE ECG SINCE I COULDN'T PUT THE STOPPED BACK IN AND I HAD TO GET A CHEST XRAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218583 ↗
• MalfunctionFeb 3, 2026Product Quality Problem

  IT WAS REPORTED BY THE CUSTOMER THAT DURING PICC LINE INSERTION, THE PULL TAB USED TO CONNECT THE 3CG SYSTEM TO THE SHERLOCK¿ CHEST PLATE WAS STRIPPED OF ITS PLASTIC PROTECTIVE COATING, RESULTING IN EXPOSED WIRE. THE FAULTY WIRE WAS NOT CONNECTED TO THE SHERLOCK CHEST PLATE. THE DEVICE ISSUE RESULTED IN A DELAY OF TREATMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251494 ↗
• MalfunctionMar 28, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT PICC DEFECT AROUND 30 CM MARK. PICC PULLED AND REPLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21726164 ↗
• MalfunctionNov 6, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED BY CUSTOMER THAT THE PICC INTRODUCER BROKE WHILE BEING USED. THERE WAS NO PATIENT HARM OR INJURY. IT CAUSED A SLIGHT DELAY IN THE PROCEDURE WHEN THE SENSOR WENT OUT HOWEVER IT WAS FINE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622966 ↗
• MalfunctionJun 18, 2024Material Deformation; Material Deformation

  IT WAS REPORTED PICC DILATOR MALFUNCTION DURING PICC PLACEMENT. TIP DEFORMED WHILE TRYING TO ADVANCE INTO SKIN. PLACED IN OTHER ARM WITH NEW PRODUCT WITHOUT INCIDENT. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION RECEIVED: A NEGATIVE EXPERIENCE TO THE PATIENT HAVING TO PERFORM THE PROCEDURE A SECOND TIME ON THE OTHER ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563570 ↗
• MalfunctionMay 6, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED RN WENT TO PRIME PICC AND THE SALINE CAME FLYING OUT OF END - THEY NOTICED THE HUB HAD A HUGE CRACK/MISSING LIP. NOTICED PRIOR TO PLACEMENT. NO PATIENT IMPACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249287 ↗
• MalfunctionMar 14, 2024Crack; Crack

  IT WAS REPORTED, "WE WERE GETTING THE PATIENT READY FOR PICC INSERTION AND PRIMING THE NEW DUAL LUMEN PICC AND NOTICED SALINE SQUIRTING OUT OF THE RED PORT WHEN FLUSHING. UPON CLOSER LOOK, THE ENTIRE RED PORT IS CRACKED AND PIECES FALLING OFF AND CLEARLY UN- USEABLE. PICC WAS PROPERLY STORED AND NOT DAMAGED IN SETTING UP TO PLACE THE DEVICE. WAS NOT USED ON PATIENT AND ALL OTHER TRAY MATTER WAS DISPOSED OF. A NEW PICC WAS SET UP AND PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909621 ↗
• InjuryFeb 8, 2024Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT PATIENT BOOKED FOR INTERVENTIONAL RADIOLOGY PROCEDURE TO RETRIEVE VASCULAR FOREIGN BODY. PROCEDURE WENT AS PLANNED. FOREIGN BODY REMOVED FROM PULMONARY ARTERY DESCRIBED AS "LINEAR FOREIGN BODY FROM LEFT LOWER LOBE PULMONARY ARTERY". FOREIGN BODY APPEARS TO BE PART OF A WIRE, FROM INSERTION OF PICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18669837 ↗
• MalfunctionJan 18, 2024Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT WHEN TAKING THE STYLET OUT IT CURLED. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED WHEN IV NURSE COMPLETED THE PICC LINE INSERTION AND TOOK THE STYLET OUT TO PLACE A MAXZERO END CAP, THE END OF THE END OF THE STYLET WAS CURLED. THE PICC LINE WAS INSERTED WITHOUT COMPLICATIONS AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18540261 ↗
• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT PICC LOOKS LIKE IT IS TORN ON THE EXTENSION LEG AND LEAKING. HAD TO INSERT ANOTHER PICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419755 ↗
• InjurySep 8, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT WHILE PICC NURSE WAS REMOVING CATHETER, THE CATHETER BREAKS FREE AND GETS ABSORBED INTO THE RIGHT UPPER BASILIC VEIN. 11.5CM OF CATHETER RECOVERED. MANUAL PRESSURE AND LATER CLEAR DRESSING APPLIED TO PICC INSERTION SITE, NO BLEEDING. ON-CALL RADIOLOGIST GETS NOTIFIED AND DEFERS CASE TO VASCULAR MD, CXR IS RECOMMENDED. DR. TO TAKE PATIENT TO SURGERY. PICC LINE TIP BROKE OFF FOREARM - RIGHT. TREATMENT WAS PROVIDED. TAKEN TO SURGERY TO REMOVE RETAINED CATHETER TIP (B)(6) 2023 SJ PICC LINE WAS POWERPICC SOLO.

  Patient problems: Foreign Body In Patient

  MAUDE report 17708914 ↗
• MalfunctionSep 1, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THERE IS LONG BLACK HAIR INSIDE OF A PICC KIT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: IT WAS REPORTED BY THE CUSTOMER ¿THE KIT CONTAMINATION WAS DISCOVERED PRIOR TO USE WITH A PATIENT AND DID NOT INVOLVE AN URGENT/LIFE-THREATENING MEDICAL SITUATION, PATIENT HARM, COMPLICATIONS, DELAY IN TREATMENT, OR NEGATIVE OUTCOME. A DIFFERENT KIT WAS USED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671047 ↗
• MalfunctionJun 28, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT PICC HUB IS DESTROYED. ADDITIONAL INFORMATION RECEIVED 06/14/2023 : THE PATIENT WAS ALREADY VERY ANXIOUS ABOUT HAVING THE LINE PLACED IN THE FIRST PLACE. IT IS UNFORTUNATE THAT SHE HAD TO UNDERGO THE PROCEDURE AGAIN. MEDICATION DELIVERY WAS DELAYED DUE TO THE FACT THAT THE DAMAGED LINE HAD TO BE REMOVED AND A NEW LINE REPLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17217294 ↗
• MalfunctionMay 25, 2023Break; Break

  PICC WAS BROKEN IN HALF AT THE SUTURE WING. THE REST OF THE PICC WAS INTACT, BUT THE EXTENSION LEGS AND LUMEN WERE LYING ON THE FLOOR. THEY BELIEVE THE PATIENT COULD HAVE INTERFERED WITH THE PICC. HAD TO INSERT ANOTHER PICC. IT WAS STATED THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004400 ↗
• MalfunctionMay 12, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  CUSTOMER REPORTED THAT THE RED PORTION OF THE DILATOR DID NOT PEEL LIKE IT SHOULD. CUSTOMER SAID PART OF THE DILATOR HAD TO BE CUT. THIN CIRCULAR RING. HAD TO STOP PROCEDURE TO CUT. PATIENT WAS URGENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924520 ↗
• MalfunctionApr 14, 2023Defective Component; Material Deformation; Defective Component; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "I HAD AN ISSUE WITH A DOUBLE LUMEN PICC THE OTHER DAY. THE SILICONE PIECE THE STOPPER WITH THE WIRE AT THE END OF THE WIRE PORT WOULD START TO "BALLOON" WHEN FLUSHED. IF FLUSHED HARD ENOUGH, I IMAGINE IT WOULD HAVE RUPTURED. THEY DID LEAVE THE PICC IN AND HAD NO ISSUES. SAID ONLY FELT A LITTLE RESISTANCE ON INSERTION." ADDITIONAL INFORMATION RECEIVED 4/10/2023: IT WAS REPORTED THAT THERE WAS NO PRESENT ISSUES OR ANY HARM THAT WAS EVIDENT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748276 ↗
• MalfunctionMar 17, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT "WHILE PUTTING ON STERILE GOWN FOR PICC PROCEDURE, CUSTOMER NOTICED A TEAR (OR RIP) IN THE SEAM BETWEEN THE GOWN SLEEVE AND THE CUFF." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566750 ↗
• MalfunctionMar 9, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY THE CUSTOMER "SHE IS HAVING ISSUES FLUSHING INTO THE PICC AND CANNOT GET A BLOOD RETURN. THE PATIENT HAD THE CATHETER PLACED (B)(6) 2023. CUSTOMER STATES SHE HAS REPOSITIONED THE PATIENT MULTIPLE TIMES. SHE TOOK THE NEEDLELESS CONNECTOR OFF OF THE PICC AND TRIED TO FLUSH DIRECTLY INTO THE PICC BUT WAS STILL UNSUCCESSFUL. SHE CALLED THE DOCTOR AND GOT AN ORDER FOR AN X-RAY. THE PICC WAS X-RAYED AND CONFIRMED IT IS PLACED PROPERLY. SHE STATES THE PATIENT RETURNED TO HER AND SHE IS STILL UNABLE TO FLUSH INTO THE PICC OR GET A BLOOD RETURN. CUSTOMER DID DESCRIBE THE PATIENT'S INTERNAL ANATOMY AS 'WEIRD'." MS&S RESPONSE: "EXPLAINED THAT BECAUSE THE PICC IS SO NEW IT IS UNLIKELY THAT FIBRIN HAS OCCLUDED THE LINE AT THIS TIME. CALLER CONFIRMS SHE IS FLUSHING WITH A 10ML SYRINGE AND THERE ARE NO CLAMPS ON THE DEVICE. DISCUSSED THAT IT IS POSSIBLE THAT THE CATHETER IS KINKED AT OR NEAR THE AXILLA AREA, POSSIBLY RELATED TO THE PATIENT'S ANATOMY. SUGGESTED THE PICC MAY NEED TO BE EVALUATED AGAIN VIA DYE STUDY TO DETERMINE IF THE PATIENT'S ANATOMY WILL SUPPORT A PICC LINE. IT IS POSSIBLE THAT THE PICC LINE ITSELF IS DAMAGED OR NOT WORKING AS INTENDED. EXPLAINED THAT WE WILL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16510653 ↗
• MalfunctionOct 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT "AFTER PLACEMENT FOR OUTPATIENT THERAPY, PATIENT RETURNED TO FACILITY WITH PICC LEAKING THROUGH THE LUMEN LEG."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15628703 ↗
• MalfunctionOct 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "PICC WAS PLACED ON PATIENT FOR OUT PATIENT THERAPY, PATIENT RETURNED TO FACILITY DUE TO CRACK IN PICC LUMEN LEG". PICC HAD TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15628556 ↗
• InjuryAug 19, 2022Material Frayed; Material Frayed

  IT WAS REPORTED BY TM "CUSTOMER IS NOT SURE ABOUT THE WIRE. WIRE COULD HAVE POTENTIALLY BROKEN OFF INSIDE PATIENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15262288 ↗
• MalfunctionJun 30, 2022Material Deformation; Material Deformation

  IT WAS REPORTED VIA MEDWATCH "PRODUCT: BARD POWERPICC SOLO 5F DL PICC, LOT# REFU2453, DEFECTIVE PART: INTRODUCER/DILATOR - WHERE THE GRAY MEETS THE WHITE TIP WHILE INSERTING THE INTRODUCER/DILATOR, THIS RN WAS HAVING A PARTICULARLY HARD TIME INSERTING INTO THE ARM. I RETRACTED THE INTRODUCER/DILATOR AND OBSERVED BUNCHING OF THE GRAY PORTION OF THE DEVICE, WHERE IT MEETS THE WHITE TIP. I IMMEDIATELY DISCARDED THE INTRODUCER/DILATOR AND REQUESTED A MICRO INTRODUCER KIT BE DROPPED ONTO THE STERILE FIELD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14879425 ↗