PowerPICC HF CatheterRecalls & reported problems across all models
Bard Access Systems, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 68
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 5 models of PowerPICC HF Catheter by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between Jun 1, 2016 and Jun 16, 2026 — classified as 4 injuries, 64 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (36 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. 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
Most reported PowerPICC HF Catheter problems
Device problems
- Fluid/Blood Leak36
- Material Deformation19
- Failure to Infuse3
- Hole In Material3
- Adverse Event Without Identified Device or Use Problem2
- Detachment of Device or Device Component2
- Device Dislodged or Dislocated2
- Kinked2
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- No Consequences Or Impact To Patient17
- No Known Impact Or Consequence To Patient4
- Discomfort3
- Pain3
- Thrombosis/Thrombus2
- Anxiety1
- Bradycardia1
PowerPICC HF Catheter models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PowerPICC HF Catheter 1385118QCatheter,intravascular,therapeutic,long-term greater than 30 days52 reports
- PowerPICC® HF Catheter 3385108QCatheter,intravascular,therapeutic,long-term greater than 30 days7 reports
- PowerPICC® HF Catheter 3385355QCatheter,intravascular,therapeutic,long-term greater than 30 days6 reports
- PowerPICC® HF Catheter 3385108QDCatheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- PowerPICC® HF Catheter 3385335QCatheter,intravascular,therapeutic,long-term greater than 30 days1 report
Recent PowerPICC HF Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Fluid/Blood Leak
IT WAS REPORTED WHEN REMOVING THE SECURACATH TO REPOSITION THE CATHETER, THEY DISCOVERED THAT THERE WAS A PINPOINT SIZE HOLE IN THE LINE AFFECTING THE WHITE LUMEN. THE GRAY AND RED LUMENS WERE UNAFFECTED WITH EXCELLENT BLOOD RETURN AND NO LEAKAGE WITH FLUSHING. MALFUNCTIONING LINE WAS REPLACED USING OVER-THE-WIRE TECHNIQUE, AND PLACEMENT VERIFIED WITH CXR PER DR'S INSTRUCTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25524203 ↗MalfunctionJun 16, 2026Device Dislodged or Dislocated
IT WAS REPORTED PICC LINE INSERTED WITHOUT INCIDENT. PLACEMENT VERIFIED WITH 3CG TECHNOLOGY. INSTRUCTED TO RETRACT LINE 2CM BY DR. DUE TO SOME BRADYCARDIA. CXR OBTAINED TO VERIFY PLACEMENT, AND RN, CONSULTED WITH RADIOLOGIST, DR. LINE WAS APPROPRIATELY TERMINATING IN "SUPERIOR CAVOATRIAL JUNCTION," BUT DR. SAID LINE WOULD BE FINE TO BE RETRACTED 2 CM. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Bradycardia
MAUDE report 25524196 ↗MalfunctionFeb 25, 2026Fluid/Blood Leak
IT WAS REPORTED VIA MEDSUN THAT RN FLUSHING PATIENT TRIPLE LUMEN PICC LINE AND NOTICED IT WAS LEAKING. IT SEEMED TO BE LEAKING FROM THE WHITE LUMEN. THE CHG [CHLORHEXIDINE GLUCONATE] PORTION ON THE DRESSING WAS BUBBLING WITH FLUID AND WAS LEAKING DOWN THE DRESSING. THERE WAS POSITIVE BLOOD RETURN ON ALL THREE LUMENS. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24444452 ↗MalfunctionFeb 25, 2026Fluid/Blood Leak
IT WAS REPORTED PICC LINE WAS SPLIT UNDERNEATH THE SECUREMENT DEVICE, CAUSING IT TO LEAK. PICC LINE WAS REPLACED ON OPPOSITE ARM. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24444428 ↗MalfunctionFeb 24, 2026Fluid/Blood Leak
IT WAS REPORTED BY MEDSUN THE GREY LUMEN OF PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINE STARTED TO LEAK WHILE FLUSHING IT. THE DEVICE WAS SECURED WITH A SECURACATH. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429116 ↗MalfunctionJan 29, 2026Fluid/Blood Leak
IT WAS REPORTED ROUTINE LINE CARE FLUSHES WERE DONE ON A TRIPLE LUMEN PICC. MAINTENANCE FLUIDS WERE INFUSING THROUGH THE RED LUMEN, AND DRESSING WAS CLEAN, DRY, AND INTACT. HOWEVER, WHEN WE FLUSHED THE NS LOCKED WHITE LUMEN, IT LEAKED SALINE FROM BENEATH THE DRESSING. WE REMOVED THE DRESSING TO INVESTIGATE, AND IT SEEMED TO BE LEAKING DIRECTLY BENEATH THE SECURE-A-CATH. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24208368 ↗MalfunctionDec 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT PICC LINE SPLIT ALONG SIDE OF LINE CAUSING 2 OF THE 3 LUMEN TO MALFUNCTION AND SPRAY LIQUID OUT THE SIDE. LINE WAS SECURED WITH SECURE-A-CATH DURING PLACEMENT AND SPLIT OCCURRED INSIDE THIS AREA OF LINE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23842496 ↗MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE PICC TEAM GOT A CALL FROM THE FLOOR NURSE IN ICU STATING THIS PATIENT HAD A TRIPLE LUMEN PICC THAT WAS LEAKING. WE WENT AHEAD AND REPLACED THE PICC IN THE OTHER LINE. LINE IS WORKING WELL WITHOUT COMPLICATIONS CURRENTLY. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821724 ↗MalfunctionNov 21, 2025Material Deformation; Material Deformation
IT WAS REPORTED WHILE ATTEMPTING TO DILATE THE VEIN DURING THE PICC INSERTION, I WAS UNABLE TO ADVANCE THE DILATOR THROUGH THE SKIN, DESPITE HAVING A 'SKIN NICK'. IT WAS NOTED THAT THE EDGES OF THE DILATOR WERE 'ROUGH' AND A NEW STERILE DILATOR WAS USED TO DILATE THE VEIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23618682 ↗MalfunctionSep 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, VASCULAR ACCESS NURSES REQUESTED TO ASSESS A TRIPLE LUMEN PICC LINE THAT WAS "LEAKING AT THE BIFURCATION." LINE HAD CHG DRESSING INTACT WITH SOME DRAINAGE. SECURE-A-CATH IN PLACE WITH CATHETER OUT 3+CM. GREY LUMEN WAS FLUSHED, AND FLUID WAS NOTED TO BE LEAKING OUT FROM UNDER DRESSING. WHEN DRESSING WAS REMOVED, PICC LINE WAS NOTED TO BE KINKED RIGHT ABOVE THE HUB, BUT 1CM BELOW THE SECURE-A-CATH. WHEN THE LINE WAS STRAIGHTENED IT WAS NOTED TO BE TORN WHERE IT WAS KINKED. CONSULTED PROVIDER TO DISCUSS WHETHER THE PICC NEEDED TO BE REPLACED FOR CONTINUED CENTRAL ACCESS. PROVIDER SAID THAT 2 PIVS WOULD BE SUFFICIENT FOR THE PATIENT. PICC REMOVED WITHOUT INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23006508 ↗MalfunctionSep 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT THE GREY LUMEN FOR A TRIPLE LUMEN PICC WAS FOUND TO BE LEAKING WHEN FLUSHING. PICC LINE WAS REMOVED AND REPLACED. LEAK WAS EXTERNAL, NO INTERVENTION, NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22963488 ↗MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED VIA MEDSUN, PATIENTS IN IMAGING RECOVERY UNDERGO A PROCEDURE WHERE THE REGISTERED NURSES AND OTHER CAREGIVERS USE A POWERPICC CATHETER AND IT LEAKS DURING USE. NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22856353 ↗MalfunctionAug 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT THE ASSESSMENT OF PICC LINE FOUND THAT ONE OF THE LINES ON A THREE LUMEN PICC WAS LEAKING AROUND THE SECUREMENT DEVICE. FLUSHED ALL THREE LINE, 2 LINES WORKED GREAT. WHITE LINE WAS FOUND TO BE LEAKING. ONCE LINE WAS PULLED. EVALUATED THE LINE MORE IN DETAIL AND FOUND A SPLIT DOWN THE SIDE OF THE PICC WHERE THE SECUREMENT DEVICE, SPLIT WAS ABOUT 1 CM. THERE WAS NOT PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22701793 ↗MalfunctionJul 30, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED IMAGING RECOVERY PICC TEAM AT FACILITY REPORTS THAT PICCS ARE LEAKING WHEN IN USE. NO OTHER INFORMATION WAS PROVIDED. THE EXACT NUMBER OF DEVICES INVOLVED WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22669440 ↗MalfunctionJul 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A PICC LINE WAS LEAKING BLOOD AND NORMAL SALINE OUT OF THE INSERTION SITE WHEN THE GREY LUMEN WAS FLUSHED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22597113 ↗
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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