PowerLineRecalls & reported problems across all models
Bard Access Systems, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 243
- Deaths reported
- 2
- Injuries reported
- 42
- Recalls
- 0
We found 6 models of PowerLine by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 243 adverse event reports in the FDA's MAUDE database, received between Jan 6, 2016 and Sep 24, 2026 — classified as 2 deaths, 42 injuries, 199 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (67 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 PowerLine problems
Device problems
- Fluid/Blood Leak67
- Fracture65
- Loss of or Failure to Bond34
- Material Separation28
- Break17
- Adverse Event Without Identified Device or Use Problem13
- Device Dislodged or Dislocated9
- Material Puncture/Hole9
Patient problems
- No Clinical Signs, Symptoms or Conditions143
- No Consequences Or Impact To Patient36
- No Known Impact Or Consequence To Patient24
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
- Bacterial Infection7
- Unspecified Infection6
- Fever4
- Pain4
PowerLine models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PowerLine 0700615Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths74 reports
- PowerLine 0700515Catheter,intravascular,therapeutic,long-term greater than 30 days65 reports
- PowerLine 0720515Catheter,intravascular,therapeutic,long-term greater than 30 days42 reports
- PowerLine 0700610Catheter,intravascular,therapeutic,long-term greater than 30 days37 reports
- PowerLine 0730615Catheter,intravascular,therapeutic,long-term greater than 30 days18 reports
- PowerLine 0730610Catheter,intravascular,therapeutic,long-term greater than 30 days7 reports
Recent PowerLine adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Packaging Problem
It was reported that medline received damaged PowerLine Central Venous Catheter device. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880015 ↗MalfunctionSep 18, 2026Nonstandard Device
On (b)(6) 2026, a patient was schedule to undergo a chronic catheter placement procedure by using the Powerline Catheter. Prior to the procedure, it was reported that the PowerLine catheter was labeled as containing a cuff however, upon inspection, no cuff was present on the catheter. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820942 ↗MalfunctionJul 14, 2026Fracture; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25814307 ↗MalfunctionJun 18, 2026Material Puncture/Hole; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT UPON RECEIPT OF PURCHASE ORDER. THE EXTERNAL SHIPPING BOX WAS OBSERVED TO BE IN GOOD CONDITION WITH NO VISIBLE DAMAGE; HOWEVER, THE PRODUCT INSIDE WAS FOUND TO BE DAMAGED, SPECIFICALLY NOTED TO HAVE A HOLE, RENDERING IT CONTAMINATED, DIRTY AND UNSUITABLE FOR USE. IN ADDITION, A QUANTITY DISCREPANCY WAS IDENTIFIED, AS ONLY ONE UNIT WAS RECEIVED INSTEAD OF THE EXPECTED ONE CASE OF FIVE UNITS, AS INDICATED IN THE PACKING LIST DOCUMENTATION. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25547027 ↗MalfunctionJun 8, 2026Fluid/Blood Leak
A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CENTRAL VENOUS CATHETER. POST THE IMPLANTATION, THE CATHETER WAS ALLEGEDLY LEAKED. THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25423267 ↗MalfunctionJun 8, 2026Fluid/Blood Leak
A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CENTRAL VENOUS CATHETER. POST THE IMPLANTATION, THE CATHETER WAS ALLEGEDLY LEAKED. THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25423100 ↗MalfunctionJun 8, 2026Fluid/Blood Leak
A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CENTRAL VENOUS CATHETER. POST THE IMPLANTATION, THE CATHETER WAS ALLEGEDLY LEAKED. THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25423098 ↗MalfunctionMay 25, 2026Fracture; Material Separation
ON (B)(6) 2025, A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING POWERLINE CENTRAL VENOUS CATHETER. POST PROCEDURE, IT WAS REPORTED THAT THE CLAMP SNAPPED OFF COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25267576 ↗MalfunctionMay 25, 2026Fracture; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING POWERLINE CENTRAL VENOUS CATHETER. POST PROCEDURE, IT WAS REPORTED THAT THE CLAMP SNAPPED OFF COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25267574 ↗InjuryMay 5, 2026Obstruction of Flow; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth
A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. POST IMPLANTATION, IT WAS REPORTED THAT THE TISSUE CUFF REPORTEDLY CAME OUT. IT WAS FURTHER REPORTED THAT THE CATHETER WAS OBSTRUCTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Skin Erosion
MAUDE report 25077617 ↗MalfunctionApr 30, 2026Fracture
A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING A POWERLINE CENTRAL VENOUS CATHETER. POST PLACEMENT, IT WAS REPORTED THAT THE CLAMPS WERE REPORTED TO BREAK FREQUENTLY, REQUIRING THE USE OF A CLAMP FROM A DIFFERENT CONNECTOR ON THE LINE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25039416 ↗MalfunctionApr 24, 2026Deformation Due to Compressive Stress; Difficult to Open or Remove Packaging Material
ON (B)(6) 2025, A PATIENT GETTING PREPARED FOR A CENTRAL LINE PLACEMENT PROCEDURE USING A POWERLINE CENTRAL VENOUS CATHETER. PRIOR TO THE PROCEDURE, THE PLASTIC COVERING ON THE TUNNELLER WAS FOUND TO BE COMPLETELY STUCK AND COULD NOT BE REMOVED. A NEW KIT HAS BEEN OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24975879 ↗MalfunctionApr 7, 2026Material Integrity Problem
THE PATIENT UNDERWENT CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CENTRAL VENOUS CATHETER. POST PROCEDURE, IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY FOUND DAMAGED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24796718 ↗MalfunctionApr 3, 2026Fracture; Material Separation; Deformation Due to Compressive Stress
ON (B)(6) 2026, THE PATIENT WAS PREPPED A CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CV CATHETER PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT TWO TRIPLE LUMEN POWERLINES WERE OPENED AND FOUND TO HAVE DAMAGED TUNNELERS. THE END THAT IS INSERTED INTO THE CATHETER WAS BENT, AND WHEN ATTEMPTS WERE MADE TO STRAIGHTEN THEM, THE TUNNELERS SNAPPED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24774396 ↗MalfunctionApr 1, 2026Fracture; Material Separation; Deformation Due to Compressive Stress
ON (B)(6) 2026, THE PATIENT WAS PREPPED A CATHETER PLACEMENT PROCEDURE USING THE POWERLINE CV CATHETER PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT TWO TRIPLE LUMEN POWERLINES WERE OPENED AND FOUND TO HAVE DAMAGED TUNNELERS. THE END THAT IS INSERTED INTO THE CATHETER WAS BENT, AND WHEN ATTEMPTS WERE MADE TO STRAIGHTEN THEM, THE TUNNELERS SNAPPED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754909 ↗
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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