PowerPort M.R.I., ChronoFlex 1806050Recalls & reported problems
Bard Access Systems, Inc. · PowerPort isp M.R.I. Implantable Port with Suture Plugs with attachable 6F ChronoFlex Polyurethane Open-Ended Single-Lumen Venous Catheter · Class 2 · Implant
All models of PowerPort M.R.I., ChronoFlex (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741026911), received between Jul 30, 2018 and Nov 7, 2025 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Adverse Event Without Identified Device or Use Problem1
- Obstruction of Flow1
- Restricted Flow rate1
Patient problems
- No Consequences Or Impact To Patient2
- Obstruction/Occlusion1
- Thrombosis/Thrombus1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23494102 ↗InjuryMay 19, 2025Restricted Flow rate; Obstruction of Flow; Restricted Flow rate; Obstruction of Flow
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE PORT WAS ALLEGEDLY OCCLUDED, AND THE PATIENT DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 22041898 ↗MalfunctionAug 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE HEALTHCARE PROVIDER WAS ALLEGEDLY UNABLE TO LOCATE THE PALPATION BUMPS TO ACCESS THE PATIENT'S PORT. THE PORT WAS ULTIMATELY ACCESSED; HOWEVER IT WAS ACCESSED AT AN ANGLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7747686 ↗MalfunctionJul 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S PORT WAS FOUND TO BE ALLEGEDLY FLIPPED AND COULD NOT BE UTILIZED. THE PATIENT FURTHER ALLEGES THAT THE PORT CAN NOT BE FLUSHED AND THE PORT IS PLANNED TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7732154 ↗
Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices
- PowerPort M.R.I., Groshong 9808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 deaths834 reports
- PowerPort ClearVUE 1608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR18 deaths571 reports
- PowerPort ClearVUE 5608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR31 deaths542 reports
- PowerPort M.R.I., ChronoFlex 1808000Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR19 deaths513 reports
- PowerPort M.R.I., ChronoFlex 1808060Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall15 deaths383 reports
- PowerPort M.R.I., Groshong 1808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR10 deaths304 reports
- PowerPort M.R.I., ChronoFlex 1829500Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 deaths197 reports
- BardPort M.R.I. 0602680Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths179 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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