PowerPICC SOLO2 Catheter with Sherlock Tip Location System (TLS) Stylet 9295118Recalls & reported problems
Bard Access Systems, Inc. · PowerPICC, Solo, · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard PowerPICC Solo2 catheter is a long-term central line placed in a vein for chemotherapy and other infusions, with a stylet used to confirm placement. The 28 reports mostly describe leaking or splitting of the catheter, sometimes with holes or cracks found when the line was removed or flushed, plus frayed material and difficulty advancing it. Reports mention no deaths and 4 injuries. No recalls name this device, and reporting dropped sharply, from 18 in the earlier 12 months to none in the most recent 12.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00801741028663), received between Jun 22, 2016 and Jun 13, 2025 — classified as 4 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak19
- Material Frayed3
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Component Missing1
- Crack1
- Failure to Advance1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient2
- Reaction2
- Swelling/ Edema2
- Anxiety1
- Burning Sensation1
- Cramp(s)1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
SAMPLE RETURNED FOR INVESTIGATION FOR LEAKING PICC.
Patient problems: Insufficient Information
MAUDE report 22205324 ↗MalfunctionApr 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT ATTENDED CHEMO UNIT FOR LINE CARE AND FOUND LEAKAGE. PICC REMOVED AND PATIENT SCHEDULED FOR NEW LINE. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21887235 ↗MalfunctionMar 14, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED OF LEAKAGE FROM SITE WHEN ACCESSED FOR IV INFUSION. PICC REMOVED. PLACED (B)(6) 2025 INTO RIGHT BASILIC VEIN, CUT 50CM EXTERNAL, 12CM SPLIT AT 12CM, SECURACATH USED IV ANTIBIOTICS, MEROPENEM, AND CLINDAMYCIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21607674 ↗MalfunctionMar 10, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT A PICC ACCESSED, AND LEAKAGE NOTED AT 6 CM EXTERNALLY, SECURACATH INSITU PICC REMOVED, AND PATIENT LISTED FOR ANOTHER PICC INSERTION. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21567508 ↗MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED ACCESSED AND LEAKAGE REPORTED, REMOVED AND SPLIT/HOLE OBSERVED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES ALL FIVE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21381575 ↗MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED PICC REMOVED DUE TO HOLE/SPLIT. PICC INSERTED (B)(6) 2024 IN TO RIGHT BRACHIAL VEIN, CUT 48CM EXTERNAL 9CM, SECURACATH INSITU, RECEIVING C1 POLAT VED R CHP CHEMOTHERAPY, UNKNOWN WHETHER USED FOR CT SCANS, UNKNOWN WHEN REMOVED BUT NEW PICC INSERTED (B)(6) SO SOME TIME IN (B)(6) AS WAS CANNULATED FOR 1 CYCLE OF CHEMO. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21381398 ↗MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED PICC ACCESSED AND SWELLING NOTED ON FLUSHING PICC REMOVED AND LEAK NOTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Swelling/ Edema
MAUDE report 21381396 ↗MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED PICC ACCESSED KINK NOTED, THEN FLUSHED AND LEAKAGE OBSERVED. PICC REMOVED AND HOLE/SPLIT NOTED. PICC INSERTED (B)(6) 2024 IN TO R BASILIC VEIN LINE, CUT TO 52CM WITH 7CM EXTERNAL, SECURACATH INSITU, REMOVED (B)(6) 2024, UNKNOWN WHAT INFUSED OR WHETHER CT SCANS WERE COMPLETED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21381395 ↗MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED PICC ACCESS AND UNABLE TO ASPIRATE, SWELLING NOTED WHEN FLUSHED PICC, REMOVED AND HOLE/SPLIT NOTED AT 7.5CM. PICC INSERTED INTO RIGHT BRACHIAL VEIN ON (B)(6) 2024, SECURACATH INSITU, CUT 47CM EXT 6CM, RECEIVING GEMCITABINE CHEMOTHERAPY, UNKNOWN WHETHER USED FOR CT SCANS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Swelling/ Edema
MAUDE report 21381393 ↗MalfunctionFeb 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, THREE PICCS WITH THREE DIFFERENT PATIENTS WERE FOUND TO HAVE SPLIT/HOLES AFTER BEING REMOVED FROM PATIENTS. THIS REPORT ADDRESSES ALL THREE DEVICES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21364313 ↗MalfunctionFeb 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, PICC ACCESSED AND LEAKAGE NOTED. PICC REMOVED AND HOLE/SPLIT OBSERVED. PICC INSERTED ON (B)(6) 2024 IN TO LEFT CEPHALIC VEIN CUT TO 48 CM WITH 6 CM EXTERNAL. RECEIVING PACLITAXEL CHEMOTHERAPY AND POSSIBLY USED FOR CT. SECURACATH INSITU. REMOVED ON (B)(6) 2024. THE PATIENT HAD CHEMOTHERAPY LEAKAGE AND HAD TO HAVE A NEW PICC INSERTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21364312 ↗MalfunctionFeb 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, PICC INSERTED (B)(6) 2024 IN TO R BRACHIAL VEIN CUT TO 55CM WITH 8CM EXTERNAL. SECURACATH INSITU, RECEIVED DOCETAXOL CHEMO. UNKNOWN WHETHER USED FOR CT. LEAK NOTED. PICC REMOVED (B)(6) 2024 DUE TO HOLE/SPLIT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21363939 ↗MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PICC INSERTED 20/8/24 INTO RIGHT BASILIS VEIN, CUT LENGTH 49CM EXTERNAL 6CM SECURACATH USED. PICC ACCESSED AND LEAKAGE NOTED DEVICE REMOVED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21360974 ↗MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A PICC LINE WAS PLACED INTO LEFT BASILIC VEIN CUT 54CM WITH 8CM EXTERNAL SECUR-A-CATH INSITU. THE PICC LINE WAS ACCESSED AND THE LEAKAGE NOTED. THE PICC WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21355949 ↗MalfunctionFeb 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, PICC INSERTED IN TO RIGHT BRACHIAL VEIN (B)(6) 2024 CUT TO 50CM AND 10CM EXTERNAL WITH SECURACATH PLACED. PICC ACCESSED (B)(6) 2025 AND INTERNAL LEAKAGE NOTED. PICC REMOVED, AND A NEW CATHETER WAS PLACED. NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21333958 ↗MalfunctionFeb 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER, PICC INSERTED INTO RIGHT BASILIC VEIN (B)(6) 2024 TRIMMED TO 50CM WITH 9CM EXTERNAL SECURACATH IN SITU REMOVED (B)(6) 2025 AFTER ACCESSING AND LEAKAGE NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21328141 ↗MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, PATIENT ATTENDED FOR CHEMOTHERAPY AND UNABLE TO BLEED OR FLUSH LINE LEAKING NOTICED AND PICC REMOVED AND HOLE SPLIT OBSERVED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21119704 ↗MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED PICC INSERTED (B)(6) 2024. PATIENT ATTENDED FOR BLOODS AND PICC FLUSH CLINICIAN UNABLE TO TAKE BLOODS OR FLUSH PICC REMOVED AND HOLE JUST INSIDE INSERTION SITE OBSERVED. PICC REMOVED (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113172 ↗MalfunctionApr 16, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A TEENAGER HAD A 5F POWERPICC SOLO INSERTED TUESDAY (B)(6). IT WAS A DIFFICULT INSERTION AND WAS OBSTRUCTED AT SUBCLAVIAN. FLUSHING WAS DIFFICULT. PATIENT CONTINUES TO HAVE PROBLEMS WHEN DEVICE IS FLUSHED/ASPIRATED. BOTH FLUSH WELL, WHEN ONE LUMEN IS ASPIRATED BLOOD IS ALSO NOTICED IN OTHER LUMEN. PICC TEAM HAVE SUGGESTED FIBRIN SHEATH. . IV INFUSIONS HAVE BEEN CARRIED OUT. (B)(6) 2021: THERE IS A SUGGESTION OF COMMUNICATION BETWEEN THE DEVICE LUMENS AND SOME FLUSHING DIFFICULTY DESPITE LUMEN PATENCY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11679316 ↗MalfunctionFeb 3, 2021Material Frayed; Break; Material Frayed; Failure to Advance
IT WAS REPORTED DURING PICC INSERTION THE CATHETER DID NOT PROGRESS. WHEN REMOVED, THE NURSE FOUND A FRAGMENT OF THE STYLET BROKEN IN THE TIP OF THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11274215 ↗MalfunctionFeb 28, 2020Material Frayed; Material Frayed
IT WAS REPORTED THAT AT THE FACILITY WHILE INSPECTING THE GUIDEWIRE, THE TIP BROKE OFF EASILY. THE DEVICE WAS NOT USED ON A PATIENT. IT WAS STATED THIS HAPPENED WITH TWO DEVICES WITH LOT NUMBER REDW1342. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9769903 ↗MalfunctionFeb 28, 2020Material Frayed; Material Frayed
IT WAS REPORTED THAT AT THE FACILITY WHILE INSPECTING THE GUIDEWIRE, THE TIP BROKE OFF EASILY. THE DEVICE WAS NOT USED ON A PATIENT. IT WAS STATED THIS HAPPENED WITH TWO DEVICES WITH LOT NUMBER REDW1342. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9769902 ↗InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD AN ADVERSE REACTION WHEN PICC WAS INSERTED. NO OTHER INFORMATION PROVIDED.
Patient problems: Reaction
MAUDE report 9453556 ↗InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD REACTION DURING INSERTION OF PICC. NO OTHER INFORMATION PROVIDED.
Patient problems: Reaction
MAUDE report 9453552 ↗MalfunctionMar 19, 2018Crack
IT WAS REPORTED THAT PICC LINES WERE CRACKING AT THE DISTAL END/HUB. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7351200 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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