PowerPICC SOLORecalls & reported problems across all models
Bard Access Systems, Inc. · 78 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one PowerPICC SOLO model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 306
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls
- 3
We found 78 models of PowerPICC SOLO by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 306 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2016 and Sep 10, 2026 — classified as 31 injuries, 275 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (94 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
PowerPICC SOLO recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 21, 2026Open, 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 · names 7 of these models · Recall details · FDA record ↗
- May 21, 2026Open, Classified
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2658-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 11, 2025Open, 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 · names 29 of these models · Recall details · FDA record ↗
Most reported PowerPICC SOLO problems
Device problems
- Fluid/Blood Leak94
- Material Deformation57
- Break19
- Material Frayed19
- Defective Component17
- Contamination /Decontamination Problem16
- Expiration Date Error9
- Activation Problem8
Patient problems
- No Clinical Signs, Symptoms or Conditions149
- No Consequences Or Impact To Patient52
- No Known Impact Or Consequence To Patient44
- Foreign Body In Patient15
- Pain14
- Swelling/ Edema9
- No Patient Involvement6
- Infiltration into Tissue4
PowerPICC SOLO models
78 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PowerPICC SOLO 1194108D5Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls58 reports
- PowerPICC SOLO 1194108D4Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls32 reports
- PowerPICC SOLO 1194108D1Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls10 reports
- PowerPICC SOLO CK000289CCatheter, intravascular, therapeutic, long-term greater than 30 days2 recalls5 reports
- PowerPICC SOLO CK000586BCatheter, intravascular, therapeutic, long-term greater than 30 days2 recalls1 report
- PowerPICC SOLO CK001030Catheter, intravascular, therapeutic, long-term greater than 30 days2 recalls0 reports
- PowerPICC SOLO 1194108D2Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall26 reports
- PowerPICC SOLO 1194108D3Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall24 reports
- PowerPICC SOLO CK000930Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall12 reports
- PowerPICC SOLO CK000687Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall5 reports
- PowerPICC SOLO CK000900Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall4 reports
- PowerPICC SOLO CK001027Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall4 reports
- PowerPICC SOLO CK000501ACatheter,intravascular,therapeutic,long-term greater than 30 days1 recall3 reports
- PowerPICC SOLO CK000524ACatheter,intravascular,therapeutic,long-term greater than 30 days1 recall2 reports
- PowerPICC SOLO CK000660Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall1 report
- PowerPICC SOLO CK000589ACatheter,intravascular,therapeutic,long-term greater than 30 days1 recall1 report
- PowerPICC SOLO CK000867Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall1 report
- PowerPICC SOLO CK000267ACatheter, intravascular, therapeutic, long-term greater than 30 days1 recall1 report
- PowerPICC SOLO CK000882Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall1 report
- PowerPICC SOLO CK000937ACatheter, intravascular, therapeutic, long-term greater than 30 days1 recall1 report
- PowerPICC SOLO CK000642Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall0 reports
- PowerPICC SOLO CK000662Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall0 reports
- PowerPICC SOLO CK000619ACatheter,intravascular,therapeutic,long-term greater than 30 days1 recall0 reports
- PowerPICC SOLO CK000721Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall0 reports
- PowerPICC SOLO CK000077DCatheter,intravascular,therapeutic,long-term greater than 30 days1 recall0 reports
- PowerPICC SOLO CK000864Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall0 reports
- PowerPICC SOLO CK000266ACatheter, intravascular, therapeutic, long-term greater than 30 days1 recall0 reports
- PowerPICC SOLO CK000894ACatheter, intravascular, therapeutic, long-term greater than 30 days1 recall0 reports
- PowerPICC SOLO CK000914Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall0 reports
- PowerPICC SOLO CK000994Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall0 reports
- PowerPICC SOLO CK000609ACatheter, intravascular, therapeutic, long-term greater than 30 days1 recall0 reports
- PowerPICC SOLO CK001028Catheter, intravascular, therapeutic, long-term greater than 30 days14 reports
- PowerPICC SOLO CK000931Catheter, intravascular, therapeutic, long-term greater than 30 days11 reports
- PowerPICC SOLO CK000458Catheter,intravascular,therapeutic,long-term greater than 30 days10 reports
- PowerPICC SOLO CK000313Catheter,intravascular,therapeutic,long-term greater than 30 days6 reports
- PowerPICC SOLO CK000408Catheter,intravascular,therapeutic,long-term greater than 30 days5 reports
- PowerPICC SOLO CK000525ACatheter,intravascular,therapeutic,long-term greater than 30 days5 reports
- PowerPICC SOLO CK000290BCatheter,intravascular,therapeutic,long-term greater than 30 days4 reports
- PowerPICC SOLO CK000590ACatheter,intravascular,therapeutic,long-term greater than 30 days4 reports
- PowerPICC SOLO CK000409Catheter,intravascular,therapeutic,long-term greater than 30 days3 reports
- PowerPICC SOLO CK000637Catheter,intravascular,therapeutic,long-term greater than 30 days3 reports
- PowerPICC SOLO CK000587ACatheter,intravascular,therapeutic,long-term greater than 30 days3 reports
- PowerPICC SOLO CK000827Catheter,intravascular,therapeutic,long-term greater than 30 days3 reports
- PowerPICC SOLO CK000410Catheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- PowerPICC SOLO CK000452Catheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- PowerPICC SOLO CK000415ACatheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- PowerPICC SOLO CK000169CCatheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- PowerPICC SOLO CK000663ACatheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- PowerPICC SOLO CK000688Catheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- PowerPICC SOLO CK000415CCatheter, intravascular, therapeutic, long-term greater than 30 days2 reports
- PowerPICC SOLO 1194108D7Catheter, intravascular, therapeutic, long-term greater than 30 days2 reports
- PowerPICC SOLO CK000004Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000314Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000248Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000045ACatheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000347Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000361Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000394Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000307ACatheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000182ACatheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000502Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000504Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000432Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000474Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000310ACatheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000434Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000451Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000544Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000504ACatheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000505ACatheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000610Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000544ACatheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000291BCatheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000502ACatheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000786Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000787Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PowerPICC SOLO CK000290CCatheter, intravascular, therapeutic, long-term greater than 30 days1 report
- PowerPICC SOLO 1194108D6Catheter, intravascular, therapeutic, long-term greater than 30 days1 report
Recent PowerPICC SOLO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Difficult or Delayed Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717370 ↗MalfunctionAug 31, 2026Material Deformation
It was reported by the customer that the wire kept bending very badly. When removed a kink and noted to the tip of the wire. No patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50525221 ↗MalfunctionAug 26, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50454721 ↗MalfunctionJun 26, 2026Fluid/Blood Leak
IT WAS REPORTED PATIENT RETURNED TO HAVE PICC REPLACED DUE TO DIFFICULTY FLUSHING AND BEING "POSITIONAL" FOR USE. ONCE PICC WAS REMOVED WAS FOUND TO HAVE A FRACTURE AT 7 CM. THE COURSE OF TREATMENT WAS NOT ALTERED AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25636233 ↗MalfunctionMay 12, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT THE PICC TEAM OPENED A POWERPICC SOLO KIT AND THERE WAS A HAIR UNDERNEATH THE TRAY. THE KIT WAS NOT USED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25154227 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT PATIENT CAME IN AS AN OUTPATIENT PICC APPOINTMENT WITH A PICC THAT HAD BEEN PLACED ONE MONTH PRIOR AND THE SOLO VALVE SEPARATED AND CUT OFF FROM THE LUMEN OF THE PICC. PATIENT NEEDED A NEW SL PICC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25020000 ↗MalfunctionApr 24, 2026Unsealed Device Packaging
IT WAS REPORTED BY THE CUSTOMER THAT MOISTURE/LIQUID FOUND INSIDE STERILE PICC KIT. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24981775 ↗MalfunctionApr 21, 2026Material Deformation
IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS DIFFICULTY WITH INTRODUCER. UPON INSPECTION, DAMAGE SEEN ON THE GRAY PIECE OF THE INTRODUCER. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24946845 ↗MalfunctionMar 4, 2026Material Deformation
IT WAS REPORTED BY THE CUSTOMER THAT ISSUE WITH A GUIDEWIRE DURING INSERTION OF A PICC LINE. THE TIP OF THE GUIDEWIRE (NOT THE ONE IN THE CATHETER) TIED IN A KNOT, AND WHEN THE NURSE ATTEMPTED TO REMOVE IT, THEY WERE UNABLE TO AND NEEDED TO NICK THE SKIN TO REMOVE IT. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24513723 ↗MalfunctionJan 22, 2026Fluid/Blood Leak
IT WAS REPORTED, PICC LINE WAS PLACED (B)(6) 2025 FOR LTA AND HAD BEEN IN FOR 18 DAYS. PATIENT CAME IN FOR ASSESSMENT OF THE PICC LINE, DRESSING HAD BEEN CHANGED AND THE DRESSING WAS DRY NOTED THAT THERE WAS AROUND 4CM EXTERNAL AND ON INSERTION THERE WAS 0 OUTSIDE THE SKIN. I FLUSHED THE PICC AND FLUID CAME OUT AND SATURATED THE DRESSING. PICC LINE WAS TAKEN DOWN AND NOTED A SPLIT IN THE CATHETER. PICC WAS REMOVED AND A MIDLINE WAS PLACED IN ORDER FOR THE ABX TREATMENT TO BE COMPLETED WHICH WAS TO BE (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24148979 ↗MalfunctionJan 16, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT WHILE INSERTING A PICC, NOTICED THAT THERE WAS A HAIR IN THE KIT. PLACER GOT A NEW PICC TO INSERT DUE TO STERILITY CONCERNS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093050 ↗MalfunctionJan 13, 2026Fluid/Blood Leak
IT WAS REPORTED, PATIENT WITH A 4FR SINGLE LUMEN PICC LINE WHICH HAS A SMALL HOLE JUST ABOVE 6CM. LINE WAS PLACED (B)(6) 2026. PATIENT STATED OVER LAST COUPLE OF WEEKS LINE WOULD BE DIFFICULTY TO FLUSH OR NOT HAVE BLOOD RETURN AND SON WOULD HAVE TO PUSH HARD WHILE FLUSHING TO GET IT TO WORK. YESTERDAY UNABLE TO FLUSH LINE SO WENT TO ER. THEY TRIED TWO DOSES OF CATHFLO WHICH DID NOT RESOLVE ISSUE. PATIENT STATES BOTH THE NURSE AND SON ATTEMPTED TO FLUSH LINE WHILE PUSHING HARD. WHEN PATIENT PRESENTED TO OUR ER, I CHANGED INJECTION CAPS AND DRESSING. NO KINKING OR OTHER ISSUE NOTED AND LINE UNABLE TO FLUSH. CXR OBTAINED AND TIP CURLED IN MID-SVC. ER PHYSICIAN RECOMMENDED RETRACTING 4CM AND WHILE RETRACTING NOTICED CLEAR FLUID LEAKING FROM SITE. I ATTEMPTED TO FLUSH AND BLOODY FLUID LEAKING FROM SITE. I REMOVED LINE AND NOTED SM HOLE JUST ABOVE 6CM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24054907 ↗MalfunctionDec 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED PLACED A POWERPICC SOLO ON (B)(6) AND IT FLUSHED FINE. ON (B)(6) THE LINE FELT OCCLUDED, THEY ADMINISTERED TPA AND IT STILL WAS OCCLUDED, THEY THEN NOTICED A PIECE OF CATHETER MATERIAL IN THE LUMEN OF THE PICC LINE. THEY TOOK THE LINE OUT OF THE PATIENT AND CUT THE LUMEN TO EXAMINE THE PIECE OF PURPLE CATHETER STUCK IN IT. PATIENT NEEDED NEW LINE PLACED AND DELAY IN CARE DUE TO NOT BEING ABLE TO USE THIS LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23851489 ↗MalfunctionDec 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED PATIENT PRESENTED TO ED REPORTING LEAKING FROM INSERTION SITE OF PICC LINE. LINE WAS REMOVED AND EVALUATED BY VAS RN. FOUND TRANSVERSE FRACTURE AT 7CM MARK. PICC LINE REMOVED, REPLACED WITH MST MIDLINE TO FINISH REMAINDER OF IV ANTIBIOTICS TREATMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23851348 ↗InjuryDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED PICC LINE THAT WAS REMOVED DUE TO A LARGE AMOUNT OF LEAKING AT THE SITE WITH FLUSHING/INFUSING. THE PATIENT WAS + FOR DVT IN THE ARM, BUT THERE WAS ALSO CONCERN THAT THE SINGLE LUMEN PICC LINE CATHETER HAD A CRACK IN IT, GIVEN THE AMOUNT OF FLUIDS COMING FROM THE INSERTION SITE WITH FLUSHING. THE PATIENT HAD A LARGE INFILTRATION OF THE ARM, THE SWELLING OF THE ARM IS WHAT PROMPTED THE NURSING STAFF TO CALL IV TEAM FOR ASSESSMENT. NO SIGNIFICANT INJURY, SWELLING DECREASED OVER 24 HOURS AFTER LINE WAS REMOVED.
Patient problems: Swelling/ Edema; Thrombosis/Thrombus
MAUDE report 23820446 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page