PowerPort, Groshong 1708560Recalls & reported problems
Bard Access Systems, Inc. · PowerPort isp Implantable Port with Attachable 8F Groshong Single-Lumen Venous Catheter Intermediate Kit (with Suture Plugs) · Class 2 · Implant
All models of PowerPort, Groshong (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741026706), received between Jul 11, 2019 and Jul 20, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
- Adverse Event Without Identified Device or Use Problem3
- Expulsion1
- Material Separation1
- Migration1
- Suction Problem1
Patient problems
- Injury3
- Unspecified Infection2
- Erythema1
- Itching Sensation1
- Rash1
- Skin Erosion1
- Swelling1
- Thrombosis/Thrombus1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT ISP. POST PROCEDURE, THE PATIENT REPORTEDLY DEVELOPED REDNESS AND TENDERNESS AT THE PORT SITE. ADDITIONALLY, THE PATIENT EXPERIENCED AN ITCHY RASH ON THE NECK. THE CURRENT PATIENT STATUS IS UNKNOWN.
Patient problems: Erythema; Itching Sensation; Rash
MAUDE report 25869653 ↗InjuryDec 18, 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 DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 23836106 ↗InjuryOct 21, 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 DEVELOPED WITH UNSPECIFIED INFECTION. REPORTEDLY THE PATIENT WAS EXPIRED, AND THE CAUSE OF DEATH WAS NOT PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 23345423 ↗InjuryMay 5, 2025Fracture; Material Separation; Expulsion; Migration; Fracture; Material Separation; Expulsion; Migration
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE PORT ALLEGEDLY ERODED, AND THE PATIENT ALLEGEDLY DEVELOPED WITH INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Skin Erosion; Unspecified Infection
MAUDE report 21961868 ↗InjuryMar 25, 2020Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY ONE YEAR SEVEN MONTHS POST PORT DEVICE IMPLANT, THE CATHETER ALLEGEDLY BROKE AT THE CONNECTION POINT AND MIGRATED TO THE HEART, WHICH WAS CONFIRMED BY X-RAY IMAGING. REPORTEDLY, THE CATHETER WAS REMOVED SURGICALLY BY INTERVENTIONAL RADIOLOGY. THE PATIENT IS REPORTED AS STABLE.
Patient problems: Injury
MAUDE report 9878245 ↗InjuryMar 25, 2020Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST PORT DEVICE IMPLANT, THE CATHETER ALLEGEDLY BROKE AT THE CONNECTION POINT AND MIGRATED TO THE HEART, WHICH WAS CONFIRMED BY X-RAY IMAGING. REPORTEDLY, THE CATHETER WAS REMOVED SURGICALLY BY INTERVENTIONAL RADIOLOGY. THE PATIENT IS REPORTED AS STABLE.
Patient problems: Injury
MAUDE report 9878242 ↗InjuryMar 25, 2020Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY ONE YEAR TWO MONTHS POST PORT DEVICE IMPLANT, THE CATHETER ALLEGEDLY BROKE AT THE CONNECTION POINT AND MIGRATED TO THE HEART, WHICH WAS CONFIRMED BY X-RAY IMAGING. REPORTEDLY, THE CATHETER WAS REMOVED SURGICALLY BY INTERVENTIONAL RADIOLOGY. THE PATIENT IS REPORTED AS STABLE.
Patient problems: Injury
MAUDE report 9878122 ↗InjuryJul 11, 2019Suction Problem; Suction Problem
IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AFTER THE PLACEMENT OF THE PORT DEVICE, IT WAS ALLEGEDLY UNABLE TO BE ASPIRATED. REPORTEDLY, THE HEALTH CARE PROVIDER WAS ABLE TO ASPIRATE SUCCESSFULLY AFTER THE ADMINISTRATION OF TISSUE PLASMINOGEN ACTIVATOR (TPA). IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED AN ALLEGED SWELLING OF THE LEFT ARM. REPORTEDLY, ON DYE STUDY FOUND THAT THE TIP OF THE PORT CATHETER WAS SLIGHTLY RETRACTED NEAR THE JUNCTION OF THE BRACHIOCEPHALIC VEINS WITHOUT EXTRAVASATION. IT WAS FURTHER REPORTED THAT AN ALLEGED THROMBUS WAS IDENTIFIED IN THE SUPERIOR VENA CAVA, LEFT BRACHIOCEPHALIC VEIN, SUBCLAVIAN VEIN AND PROXIMAL ASPECT OF THE CEPHALIC VEIN. REPORTEDLY, AN ADDITIONAL INTERVENTION WAS REQUIRED FOR THROMBUS FORMATION AND PREVENTION, HOWEVER, THE PATIENT WAS REPORTEDLY STABLE.
Patient problems: Swelling; Thrombus
MAUDE report 8781678 ↗
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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