PowerPort, ChronoFlexRecalls & reported problems across all models
Bard Access Systems, Inc. · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 559
- Deaths reported
- 22
- Injuries reported
- 401
- Recalls
- 0
We found 16 models of PowerPort, ChronoFlex by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 559 adverse event reports in the FDA's MAUDE database, received between Jan 26, 2018 and Sep 30, 2026 — classified as 22 deaths, 401 injuries, 136 malfunctions.
The most frequently reported specific device problem is “Fracture” (71 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 PowerPort, ChronoFlex problems
Device problems
- Adverse Event Without Identified Device or Use Problem313
- Fracture71
- Suction Problem43
- Device Appears to Trigger Rejection36
- Obstruction of Flow32
- Fluid/Blood Leak29
- Difficult to Flush27
- Migration25
Patient problems
- Unspecified Infection234
- Thrombosis/Thrombus154
- No Clinical Signs, Symptoms or Conditions101
- No Consequences Or Impact To Patient31
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available30
- Pain30
- Bacterial Infection22
- Sepsis21
PowerPort, ChronoFlex models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PowerPort, ChronoFlex 1708000PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR5 deaths160 reports
- PowerPort, ChronoFlex 1716000PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR4 deaths127 reports
- PowerPort, ChronoFlex 1708060PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR4 deaths86 reports
- PowerPort, ChronoFlex 1708001PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths37 reports
- PowerPort, ChronoFlex 1706060PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR29 reports
- PowerPort, ChronoFlex 1708061PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR29 reports
- PowerPort, ChronoFlex 1716001PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths28 reports
- PowerPort, ChronoFlex 1708062PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR17 reports
- PowerPort, ChronoFlex 1706061PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths11 reports
- PowerPort, ChronoFlex 4708060PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths11 reports
- PowerPort, ChronoFlex 1708050PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death10 reports
- PowerPort, ChronoFlex 1708070PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR7 reports
- PowerPort, ChronoFlex 1706050PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR4 reports
- PowerPort, ChronoFlex 1708051PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- PowerPort, ChronoFlex 4708061PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- PowerPort, ChronoFlex CP00008PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
Recent PowerPort, ChronoFlex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Appears to Trigger Rejection
It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with thrombosis. However, the current status of the patient was unknown.
Patient problems: Thrombosis/Thrombus
MAUDE report 50943559 ↗MalfunctionSep 30, 2026Material Integrity Problem
A patient underwent a port removal procedure because treatment was no longer required. The port was implanted on (b)(6) 2026, and removed on (b)(6) 2026. During the removal procedure, Interventional Radiology staff observed that the septum of the purple PowerPort was damaged beyond normal wear and tear. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943533 ↗InjurySep 29, 2026Fluid/Blood Leak
It was reported through the litigation process that, sometime after the port placement, device leakage was reported. Additionally, the patient was diagnosed with an unspecified infection, sepsis, and methicillin resistant Staphylococcus aureus (MRSA) bacteremia. However, the current status of the patient was unknown.
Patient problems: Drug Resistant Bacterial Infection; Extravasation; Sepsis; Unspecified Infection
MAUDE report 50928876 ↗InjurySep 28, 2026Expulsion
It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with an unspecified infection, erosion and wound complications. However, the current status of the patient was unknown.
Patient problems: Skin Erosion; Unspecified Infection
MAUDE report 50911165 ↗InjurySep 25, 2026Device Appears to Trigger Rejection
It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with thrombosis. However, the current status of the patient was unknown.
Patient problems: Thrombosis/Thrombus
MAUDE report 50894478 ↗MalfunctionSep 24, 2026Material Integrity Problem
On (b)(6) 2026, a patient underwent a port placement procedure using the PowerPort Slim. On (b)(6) 2026, upon removal, damage was observed on the silicone portion of the port. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881886 ↗MalfunctionSep 24, 2026Tear, Rip or Hole in Device Packaging
On (b)(6) 2026, a patient underwent a port placement procedure using PowerPort Slim. Prior to the procedure, during inspection, it was noted that the tunneler in two port kits had breached the sterile barrier of the packaging. The procedure was completed using another device. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880531 ↗MalfunctionSep 24, 2026Tear, Rip or Hole in Device Packaging
On (b)(6) 2026, a patient underwent a port placement procedure using PowerPort Slim. Prior to the procedure, during inspection, it was noted that the tunneler in two port kits had breached the sterile barrier of the packaging. The procedure was completed using another device. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880530 ↗MalfunctionSep 24, 2026Blocked Connection; Loosening of Implant Not Related to Bone-Ingrowth
It was reported through the litigation process that, sometime after the port placement, the port body allegedly exhibited positional instability and movement within the subcutaneous tissue, resulting in repeated inability to access the port catheter without fluoroscopic guidance and requiring multiple interventional radiology visits for fluoroscopy guided access. However, there was no patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877877 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with an unspecified infection. However, the current status of the patient was unknown.
Patient problems: Unspecified Infection
MAUDE report 50865892 ↗InjurySep 7, 2026Device Appears to Trigger Rejection
It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with thrombosis. However, the current status of the patient was unknown.
Patient problems: Thrombosis/Thrombus
MAUDE report 50646229 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
It was reported through the litigation process that, on (b)(6)2021, a patient underwent a port placement procedure via the right subclavian vein. Approximately three months and sixteen days later, on (b)(6)2021, blood culture testing reportedly revealed Staphylococcus aureus bacteremia. On the same date, the right chest mediport was removed. During the removal procedure, purulent material was observed within the port pocket, and cultures were obtained from the pocket and catheter tip. However, the current status of the patient remains unknown.
Patient problems: Bacteremia; Purulent Discharge
MAUDE report 50560458 ↗InjuryAug 20, 2026Fluid/Blood Leak; Difficult to Flush; Device Tipped Over; Blocked Connection
It was reported through the litigation process that, sometime after the port placement, the port allegedly flipped or rotated within the pocket, causing difficulty with cannulation, inability to access the port, port malfunction, and medication leakage from the port. Additionally, the patient was diagnosed with an unspecified infection. However, the current status of the patient remains unknown.
Patient problems: Extravasation; Unspecified Infection
MAUDE report 50341150 ↗InjuryAug 20, 2026Fluid/Blood Leak; Difficult to Flush; Device Tipped Over; Blocked Connection
It was reported through the litigation process that, sometime after the port placement, the port allegedly flipped or rotated within the pocket, causing difficulty with cannulation, inability to access the port, port malfunction, and medication leakage from the port. Additionally, the patient was diagnosed with an unspecified infection. However, the current status of the patient remains unknown.
Patient problems: Extravasation; Unspecified Infection
MAUDE report 50338460 ↗InjuryAug 17, 2026Device Appears to Trigger Rejection; Migration
It was reported through the litigation process that, sometime after the port placement, the device allegedly migrated. Additionally, the patient was diagnosed with thrombosis and pulmonary embolism. However, the current status of the patient was unknown.
Patient problems: Pulmonary Embolism; Thrombosis/Thrombus
MAUDE report 50271764 ↗
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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