PowerPICC Provena SOLO S1295108FD5Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741155215), received between Oct 5, 2018 and May 27, 2026 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT RESISTANCE MET WHILE RETRACTING GUIDEWIRE. WHEN REMOVED, THE WIRE WAS UNCOILED.

  Patient problems: Insufficient Information

  MAUDE report 25300788 ↗
• MalfunctionJan 26, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE DIRECTOR OF CATH LAB THAT A LONG COILED HAIR WAS FOUND WITHIN A STERILIZED PICC KIT. IT WAS STATED THE KIT WAS NOT USED ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250119 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE CUSTOMER IS EXPERIENCING DVTS WITH A PARTICULAR LOT NUMBER. THE LINE WAS REMOVED AND PATIENT TREATED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15932631 ↗
• MalfunctionApr 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PICC LINE HAD A HOLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053258 ↗
• MalfunctionOct 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED PICC NURSE HAD TROUBLE INSERTING THE DILATOR. WHEN SHE PULLED IT OUT IT HAD FOLDED UP ON ITSELF. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12672397 ↗
• InjuryOct 13, 2021Material Frayed; Material Frayed

  IT WAS REPORTED VIA MS&S "CUSTOMER CALLED TO REQUEST EDUCATIONAL MATERIALS FOR A POWERPICC. SHE REPORTED THAT THEY HAD THE TIP OF THE STYLET BREAK OFF IN A PATIENT AND LODGE IN THE RIGHT VENTRICLE ON (B)(6). SHE REPORTED THIS TO MED WATCH. THE FOREIGN BODY WAS DISCOVERED TWO WEEKS AFTER WHEN THE PATIENT CAME BACK TO THE HOSPITAL FOR A DIFFERENT REASON, BUT A CT WAS PERFORMED AND THE STYLET TIP WAS DISCOVERED AT THAT POINT. SHE REPORTED THAT PATIENT DID NOT SUFFER ANY ADVERSE EFFECTS, OTHER THEN HAVING TO HAVE A PROCEDURE TO REMOVE THE TIP." MS&S RESPONSE: "I PROVIDED THE PROVENA IFU AND FORWARDED THE CASE TO PRODUCT COMPLAINTS." ADDITIONAL INFORMATION RECEIVED 09/28/2021 "DATE OF INSERTION: (B)(6) 2021. THE PICC INSERTION NURSE REPORTS THE PICC LINE INSERTION WAS UNEVENTFUL. SHE INSERTED THE PICC IN THE LEFT ARM DUE TO PATIENT HAVING OSTEOMYELITIS, GANGRENE OF RIGHT THUMB AND NOTED SWELLING UP THE RIGHT FOREARM. THE PICC LINE WAS NOT TRIMMED AT ALL DUE TO EXTRA LENGTH NEEDED FOR LEFT SIDED PICC. PROCEDURE TOOK APPROXIMATELY 25 TO 30 MINUTES AND PROPER PLACEMENT WAS CONFIRMED BY RADIOLOGIST. THE RADIOLOGIST DID NOT SEE THE FOREIGN BODY ON INITIAL CONFIRM PLACEMENT X-RAY. HE WAS LOOK

  Patient problems: Foreign Body In Patient

  MAUDE report 12628154 ↗
• InjurySep 7, 2021Material Fragmentation

  PICC INSERTION ON (B)(6) 2021. X-RAY OF PICC LINE PLACEMENT PERFORMED AND NO FOREIGN BODY NOTES. PATIENT WAS DISCHARGED HOME WITH ON (B)(6) 2021. RETURNED TO EMERGENCY ROOM WITH INTRACTABLE NAUSEA AND VOMITING. SHE ALSO HAD REPORTED SOME SOB AND CHEST PAIN FOR PAST SEVERAL DAYS PRIOR. CT SCAN ORDERED OF CHEST AND ABDOMEN. A FOREIGN BODY NOTED IN HEART ON CT SCAN. A CHEST X-RAY WAS OBTAINED AND CONFIRMED FOREIGN BODY IN RIGHT VENTRICLE OF HEART. HEART CAUTERIZATIONS PERFORMED TO REMOVE THE FOREIGN BODY. CARDIOLOGIST WAS ABLE TO REMOVE THE FOREIGN BODY WHICH IS BELIEVED TO BE A PIECE OF THE PICC INSERTION GUIDEWIRE. THE FOREIGN BODY APPROXIMATELY 1 TO 1 1/2 INCHES IN LENGTH. FOREIGN BODY WAS PLACED IN A CONTAINER AND TRANSPORTED TO LABORATORY FOR FURTHER INSPECTION. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Chest Pain; Dyspnea; Foreign Body In Patient; Nausea; Vomiting

  MAUDE report 12438741 ↗
• InjuryMar 18, 2020Material Frayed; Material Frayed

  IT WAS REPORTED PER RECEIVED MEDWATCH "PICC INSERTION WITH SHERLOCK 3CG PLACEMENT VERIFIED LINE IN SUPERIOR VENA CAVA. HAD SOME DIFFICULTY GETTING PICC LINE TO DROP IN SUPERIOR VENA CAVA PRIOR. IT APPEARED TO BE GOING UP INTO INTERNAL JUGULAR AND CIRCLING PER MONITOR. ONCE IN PLACE I ATTEMPTED TO PULL WIRE OUT AND HEARD A POP EXAMINED WIRE IT APPEARED BROKEN. PULLED PICC LINE OUT HOPING WIRE MAY STILL BE IN CATHETER AND CHECKED FOR THE ENTIRE 40CM LINE WAS INTACT. ORDERED FOR STAT CHEST X-RAY AND STAT CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) TO BE SAFE. STARTED PIV FOR CTA AND IT CONFIRMED 3.7CM WIRE LEFT INPATIENT RIGHT SUBCLAVIAN VEIN. INFORMED HOUSE SUPERVISOR, PRIMARY MD, IR DIRECTOR AND IR MD. SAVED PICC LINE AND WIRE FOR REVIEW AND IR RETRIEVED A 3.7CM WIRE FROM PATIENT".

  Patient problems: Foreign Body In Patient

  MAUDE report 9848487 ↗
• InjuryFeb 22, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RN INSERTED A PICC IN A PATIENT AND A PIECE OF THE 3CG STYLET TIP BROKE OFF IN THE PATIENTS ARM. IT IS REPORTED THAT THE PIECE OF WIRE WAS SUCCESSFULLY REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8363171 ↗
• InjuryNov 16, 2018Break; Material Fragmentation

  IT WAS REPORTED THAT DURING PLACEMENT THE TIP OF THE 3CG WIRE BROKE OFF INSIDE THE PATIENT. IR DETECTED IT UNDER FLURO. PATIENT TRANSFERRED TO VASCULAR SURGEON FOR REMOVAL OF 3CG STYLET TIP. ADDITIONAL INFORMATION RECEIVED FROM MS&S STATED, "FROM [TERRITORY MANAGER'S] DESCRIPTION OF THE EVENT IT SOUNDED LIKE THE INSERTER HIT AN OBSTRUCTION AND KEPT TRYING TO PUSH THE PICC THROUGH THE OBSTRUCTION AND THEN HAD DIFFICULTY REMOVING THE PICC." ADDITIONAL INFORMATION STATED, "THE STYLET FRAGMENT WAS REMOVED." ON (B)(6) 2018 PER MEDWATCH: THE PATIENT PRESENTED FOR PLACEMENT OF A PICC. NURSING STAFF REPORTED THAT DURING THE INSERTION PROCESS, THEY DISCOVERED THAT A PORTION OF THE WIRE HAD BROKEN OFF AND REMAINED IN THE PATIENT. AFTER CONSULTATION WITH RADIOLOGIST AND PATIENT'S PHYSICIAN, THE DECISION WAS MADE TO TRANSFER PATIENT TO HOSPITAL TO HAVE THE BROKEN PIECE OF THE WIRE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8077767 ↗
• MalfunctionOct 5, 2018Break

  IT WAS REPORTED THAT THE PLACEMENT OF A PICC IN THE RIGHT UPPER ARM WAS UNSUCCESSFUL. UPON INSPECTION OF THE DEVICE IT WAS REPORTED THAT THE STYLET WAS BROKEN. ANOTHER PICC WAS SUCCESSFULLY PLACE IN THE LEFT UPPER ARM. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED: FACILITY REPORTED A "HARD" INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7939560 ↗