PowerPICC CathetersRecalls & reported problems across all models
Bard Access Systems, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one PowerPICC Catheters model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 354
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls
- 2
We found 3 models of PowerPICC Catheters by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 354 adverse event reports in the FDA's MAUDE database, received between Nov 3, 2015 and Jul 14, 2026 — classified as 27 injuries, 327 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (166 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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 Catheters 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 · 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 · Recall details · FDA record ↗
Most reported PowerPICC Catheters problems
Device problems
- Fluid/Blood Leak166
- Material Deformation73
- Break25
- Material Twisted/Bent21
- Material Frayed18
- Contamination /Decontamination Problem8
- Leak/Splash8
- Activation Problem7
Patient problems
- No Clinical Signs, Symptoms or Conditions204
- No Known Impact Or Consequence To Patient65
- No Consequences Or Impact To Patient42
- Foreign Body In Patient12
- Pain5
- Insufficient Information4
- No Information4
- No Patient Involvement4
PowerPICC Catheters models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PowerPICC® Catheters 1174108DCatheter,intravascular,therapeutic,long-term greater than 30 days1 recall222 reports
- PowerPICC® Catheters 1275108DCatheter,intravascular,therapeutic,long-term greater than 30 days1 recall115 reports
- PowerPICC® Catheters 1385108QCatheter,intravascular,therapeutic,long-term greater than 30 days17 reports
Recent PowerPICC Catheters adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2026Material Deformation
IT WAS REPORTED BY CUSTOMER THAT FEW INTRODUCERS THAT HAVE BEEN REALLY DIFFICULT TO INTRODUCE, CAUSING US TO OPEN A WHOLE NEW KIT. ADDITIONAL INFORMATION RECEIVED 19-MAY-2026: THE INSERTIONS WERE NOT DIFFICULT UNTIL THE PICC NURSE GOT TO THE INTRODUCER PART. AT THAT POINT, UPON INTRODUCTION THERE WAS SOME DIFFICULTY AND THEN A LIP THAT DEVELOPED MAKING IT IMPOSSIBLE TO CONTINUE EVEN WITH FURTHER DERMATOTOMY. THIS RESULTED IN ANOTHER KIT HAVING TO BE OPENED. NO FURTHER DETAILS PROVIDED. 06/30/2026 IT WAS FOUND DURING INVESTIGATION THAT REVEALED A BEND ON THE MICROINTRODUCER SHAFT AND DAMAGE AT THE SHEATH TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815342 ↗MalfunctionMay 13, 2026Material Deformation
IT WAS REPORTED BY THE CUSTOMER THAT IRREGULAR EDGE ON DILATOR IN PICC KIT THAT WILL NOT PUSH THROUGH THE VEIN. HAD TO PULL NEW DILATOR AND FINISHED THE LINE - UNKNOWN IF ANY DAMAGE DONE TO THE VESSEL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164097 ↗MalfunctionFeb 23, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THEY WERE INSTRUCTED TO RETRACT THE PICC BASED ON THE CHEST X-RAY FINDING. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24422841 ↗MalfunctionFeb 23, 2026Device Markings/Labelling Problem
IT WAS REPORTED THAT THE PATIENT HAS HAD THEIR PICC IN PLACE SINCE (B)(6) 2025. WE WERE INSTRUCTED TO RETRACT THE PICC BASED ON CXR FINDING. WHEN CLINICIAN RETRACTED THE PICC, THERE WERE NO MARKINGS ON THE PICC. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24422231 ↗MalfunctionFeb 2, 2026Fluid/Blood Leak
IT WAS REPORTED THAT 4FR DL SV WITH A HOLE. THE HOLE IS RIGHT BELOW THE HUB. NO FURTHER DETAILS AVAILABLE OR PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24235310 ↗MalfunctionJan 8, 2026Contamination /Decontamination Problem; Material Deformation
ADDITIONAL INFORMATION RECEIVED 1/5/2026: THE PATIENT REQUIRED PICC REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003008 ↗MalfunctionJan 7, 2026Product Quality Problem
IT WAS REPORTED PICC WASN'T WORKING SO NURSE REMOVED IT AND SAW ONE OF THE PIGTAILS WERE STRETCHED OUT LONGER THAN THE OTHER. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23996367 ↗MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT 5F DL PICC LEAKING AT JUNCTION BETWEEN PICC AND END CAP/CONNECTOR. LINE PULLED FROM PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23709773 ↗MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT 5F DL PICC LEAKING AT JUNCTION BETWEEN PICC AND END CAP/CONNECTOR. LINE PULLED FROM PATIENT. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23709335 ↗MalfunctionNov 25, 2025Material Frayed; Material Twisted/Bent; Material Frayed; Material Twisted/Bent
IT WAS REPORTED GUIDEWIRE NOTED TO BE DIFFICULT TO REMOVE AND REPLACE IN LINE PRIOR TO PLACEMENT IN PATIENT. UPON REMOVAL, GUIDEWIRE CURLED LIKE A RIBBON AND MADE THE LINE UNUSABLE. PATIENT'S SKIN WAS SHREDDED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Abrasion
MAUDE report 23646606 ↗MalfunctionNov 25, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ADDITIONAL INFORMATION: WE WERE NOT INFORMED OF ANY LEAKAGE THAT OCCURRED PRIOR TO THE INCIDENT OF ATTEMPTED REMOVAL. THE PATIENT WAS ON DAPTOMYCIN 450MG ONCE DAILY INFUSED OVER 30MIN, ZOSYN 3.375GM Q8HR INFUSED OVER 4H, AND NS AT 100ML/HR CONTINUOUSLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645915 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT A PICC BROKE. PATIENT WAS WHEELING HER WHEELCHAIR AND HEARD SOMETHING HIT THE FLOOR...IT WAS THE TOP OF HER PICC. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22714557 ↗MalfunctionJul 14, 2025Activation Problem; Activation Problem
IT WAS REPORTED BY CUSTOMER THAT SAFETY NEEDLE MALFUNCTION, GREEN CAP CAME COMPLETELY OFF THE END. NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22500360 ↗MalfunctionJul 10, 2025Material Deformation; Material Deformation
IT WAS REPORTED BY THE CUSTOMER DURING SINGLE LUMEN 4FR PICC INSERTION, RESISTANCE MET BUT ABLE TO FULLY PASS CATHETER. MULTIPLE PASSES MADE WITH PATIENT PERFORMING VAGAL MANEUVERS AND POSITION CHANGES AS PICC WOULD NOT DROP. WHEN 3CG WIRE WAS REMOVED FROM CATHETER AND INSPECTED, KINK NOTED AND CATHETER INTEGRITY APPEARED TO BE COMPROMISED. THIS WIRE WAS IMMEDIATELY REMOVED FROM THE PROCEDURE AND A NEW KIT WAS USED FOR THE REST OF THE PROCEDURE AND TIP OF CATHETER WAS PRESENT UPON INSPECTION. NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22468119 ↗MalfunctionJul 1, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT PICC LINE HAS A HOLE AND LEAKS AT THE 5CM MARK. PATIENT NEEDED NEW LINE PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22378954 ↗
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.
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