PowerPICC Provena SOLO S1295108FD2Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741154904), received between Nov 21, 2018 and Nov 4, 2024 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Defective Component” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2024

  DURING INSERTION OF DOUBLE LUMEN PICC THERE WAS NO ECG READING FROM THE WIRE IN THE PICC TO THE ULTRASOUND MACHINE. ALL CONNECTIONS WERE CHECKED. THE WIRE INSIDE THE PICC WAS REMOVED . THERE WERE TWO PLACES FROM THE TIP EXTENDING 3 INCHES THAT APPEARED BENT. THE PIECE CLOSEST TO THE TIP OF THE WIRE BROKE OFF ONTO THE STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20597954 ↗
• MalfunctionAug 28, 2024Material Frayed; Unable to Obtain Readings; Material Frayed; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING INSERTION THERE WAS NO ECG READING FROM THE WIRE IN THE PICC TO THE SHERLOCK. AFTER TROUBLESHOOTING TO ENSURE THE ECG LEADS WERE CORRECTLY ON THE PATIENT, THE FIN ON THE SHERLOCK, AND THE CONNECTION FROM THE SHERLOCK TO THE MACHINE. STILL NOTHING WORKED. THE WIRE INSIDE THE PICC WAS REMOVED AS LOOKED AT AND THERE WERE TWO PLACES FROM THE TIP EXTENDING 3 INCHES THAT APPEARED BENT. THE PIECE CLOSES TO THE TIP OF THE WIRE BROKE OFF IN 3 PIECE (OUTSIDE OF THE PATIENT). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091890 ↗
• MalfunctionAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CUSTOMER THAT NURSE INSERTED PICC AND RECEIVED NASAL AND THROAT IRRITATION FROM OUR MASK IN THE KIT. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: Sore Throat

  MAUDE report 20057813 ↗
• MalfunctionAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NURSE INSERTED BD PICC AND GOT NASAL AND THROAT IRRITATIONS FROM OUR MASK IN THE KIT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Sore Throat

  MAUDE report 20057763 ↗
• MalfunctionApr 4, 2024Material Frayed; Contamination /Decontamination Problem; Material Frayed; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE INTRODUCER GUIDEWIRE HAS "SOMETHING" HANGING OFF THE END. THE PATIENT EXPRESSED PAIN AND DISCOMFORT WHEN CLINICIAN TRIED TO INSERT THE WIRE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Pain

  MAUDE report 19041068 ↗
• MalfunctionJun 15, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER ON 5/21/23 "LEAKING AROUND WIRE AND RUBBER PORT". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140586 ↗
• MalfunctionJun 15, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER "PICC LEAKING AROUND WIRE AND RUBBER PORT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139788 ↗
• MalfunctionJun 15, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT INTRODUCER WOULD NOT STAY TIGHT, HAD TO DROP IN MICROINTRODUCER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139464 ↗
• MalfunctionJun 14, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER ON (B)(6) 2023 "LEAKING AROUND WIRE AND RUBBER PORT". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124559 ↗
• MalfunctionJun 14, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER ON (B)(6) 2023 "LEAKING AROUND WIRE AND RUBBER PORT". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124453 ↗
• MalfunctionFeb 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT "RN STATES SHE GOT CALLED TO ASSESS A PICC THAT WAS LEAKING. WHEN RN WENT TO ASSESS THE PATIENT THE PICC WAS AROUND THE 6CM MARK. STATES THE PREVIOUS NURSE CHARTED THAT WHEN SHE PLACED THE PICC IT WAS AT THE 0CM MARK. WHEN RN WENT TO FLUSH THE LINE, SHE NOTED LEAKING AROUND THE 6CM MARK. NO FURTHER INFORMATION PROVIDED ON HOW PLACEMENT WAS. ONLY INFORMATION THAT THE ACCOUNT WAS ABLE TO GIVE WAS WHEN THEY WENT TO ASSESS THE PICC. STAT LOCK USED WAS THE BD STAT LOCK USED IN THE PICC KITS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16439902 ↗
• MalfunctionApr 29, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED "PICC NURSE REPORTED THE FOLLOWING. "PLACED A DL PICC AND THE PEEL-AWAY SHEATH BROKE APART AS I WAS PEELING IT. NO HARD WAS DONE, WAS ABLE TO GRAB AND REMOVE THE WHOLE THING. THE RED HANDLE JUST COMPLETELY BROKE OFF THE SHEATH ON THE ONE SIDE". PICC NURSE REPORTED THAT THE PICC WAS A VERY SMOOTH INSERTION, NOTHING OUT OF THE ORDINARY. WHEN SHE SNAPPED THE RED HANDLES APART AND STARTED PULLING IT DIDN' T FEEL ABNORMAL. REPORTS SHE ONLY NOTICED BECAUSE SHE LOOKED AT THE SHEATH AFTER REMOVAL AND ONE SIDE WAS NOT THERE. LOOKED DOWN AND IT WAS STILL MOSTLY IN THE ARM. THERE WAS MAYBE 1/4 INCH EXTERNAL SO SHE GRABBED IT AND PULLED IT OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14251639 ↗
• MalfunctionOct 27, 2021Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "PREPARING PICC LINE FOR INSERTION I PULLED THE GUIDE WIRE BACK TO TRIM THE PICC PRIOR TO PLACEMENT AND IT BROKE FREE FROM THE YELLOW PLASTIC CONNECTION THAT CONNECTS TO THE SHERLOCK 3CG DEVICE. I WAS UNABLE TO USE THE PICC KIT AND HAD TO OPEN ANOTHER KIT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704137 ↗
• InjuryJul 31, 2019Break

  IT WAS REPORTED THAT THE 3CG WIRE BROKEN DURING INSERTION OF THE PICC. IT WAS STATED THAT 4CM OF THE WIRE HAD TO BE REMOVED FROM THE PATIENT. ON 07/16/2019- ADDITIONAL INFORMATION FROM THE FACILITY STATED, "INITIAL STICK WAS EASY AND UNCOMPLICATED, BUT THEN PICC RN MET RESISTANCE WHEN ADVANCING THE CATHETER SO PICC RN STOPPED ADVANCING, REPOSITIONED THE PATIENT, AND ATTEMPTED TO ADVANCE AGAIN. WHEN THIS WAS NOT POSSIBLE, PICC RN ABORTED THE ATTEMPT. PICC RN COMMENTED SINCE THE LAST EVENT, PICC RN IS VERY CAUTIOUS AND DOES NOT ATTEMPT TO AFTER UNSUCCESSFUL PICC INSERTION, THE STYLET WHICH WAS PRELOADED IN THE CATHETER WAS FOUND BROKEN. A CHEST XRAY WAS PERFORMED AND RADIOLOGIST READ "AN INTERVAL NEW APPROXIMATELY 3-4 CM PARTIALLY COILED WIRE PROJECTING INFERIOR TO THE TIP OF THE LEFT PICC LINE, MAY REPRESENT RETAINED WIRE." IMMEDIATELY, MD WERE NOTIFIED. THE PATIENT HAD TO GO TO IR TO HAVE BROKEN STYLET REMOVED"

  Patient problems: Foreign Body In Patient

  MAUDE report 8848896 ↗
• MalfunctionJun 21, 2019Break; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER WAS LEAKING FROM THE RED LUMEN AT THE BIFURCATION. (B)(6) 2019- ADDITIONAL INFORMATION RECEIVED FROM FACILITY STATED, "UPON COMPLETION OF INSERTION WE NOTICED DAMAGED WHEREAS LEAKING WAS NOTICED. DAMAGED PICC WAS REPLACED AND HAVE TO START A NEW PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8724340 ↗
• MalfunctionDec 7, 2018Material Twisted/Bent

  IT WAS REPORTED THAT THE STYLET WAS KINKED UPON REMOVAL AFTER SUCCESSFUL PICC PLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8142196 ↗
• InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS CLOTTING WITH THE PICC LINE. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES PATIENT #4 AND LOT NUMBER RECU1031.

  Patient problems: Thrombus

  MAUDE report 8095813 ↗