PowerPort M.R.I., ChronoFlexRecalls & reported problems across all models

We found 22 models of PowerPort M.R.I., ChronoFlex by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 1,642 adverse event reports in the FDA's MAUDE database, received between Aug 26, 2016 and Sep 30, 2026 — classified as 59 deaths, 1,111 injuries, 472 malfunctions.

The most frequently reported specific device problem is “Fracture” (185 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

PowerPort M.R.I., ChronoFlex recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 14, 2019Open, Classified

   Complaints received that products packaged with the incorrect introducer sheath size.

   Z-0582-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported PowerPort M.R.I., ChronoFlex problems

PowerPort M.R.I., ChronoFlex models

22 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PowerPort M.R.I., ChronoFlex 1808000

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  19 deaths513 reports
• PowerPort M.R.I., ChronoFlex 1808060

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall15 deaths383 reports
• PowerPort M.R.I., ChronoFlex 1829500

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  6 deaths197 reports
• PowerPort M.R.I., ChronoFlex 1808001

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  6 deaths69 reports
• PowerPort M.R.I., ChronoFlex 4808060

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  2 deaths65 reports
• PowerPort M.R.I., ChronoFlex 1808062

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  4 deaths58 reports
• PowerPort M.R.I., ChronoFlex 5829502

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 death51 reports
• PowerPort M.R.I., ChronoFlex 1808061

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 death45 reports
• PowerPort M.R.I., ChronoFlex 1808069

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  4 deaths41 reports
• PowerPort M.R.I., ChronoFlex 1808050

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  40 reports
• PowerPort M.R.I., ChronoFlex 4808061

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  34 reports
• PowerPort M.R.I., ChronoFlex 1806060

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  33 reports
• PowerPort M.R.I., ChronoFlex 1808002

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  30 reports
• PowerPort M.R.I., ChronoFlex 1829570

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  20 reports
• PowerPort M.R.I., ChronoFlex 1806061

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  16 reports
• PowerPort M.R.I., ChronoFlex 1806062

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  10 reports
• PowerPort M.R.I., ChronoFlex 1808070

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  10 reports
• PowerPort M.R.I., ChronoFlex 1808051

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  9 reports
• PowerPort M.R.I., ChronoFlex 1808052

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  6 reports
• PowerPort M.R.I., ChronoFlex 1808071

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 death5 reports
• PowerPort M.R.I., ChronoFlex 1806050

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  4 reports
• PowerPort M.R.I., ChronoFlex 5829500

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  3 reports

Recent PowerPort M.R.I., 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 50944380 ↗
• MalfunctionSep 29, 2026Deformation Due to Compressive Stress

  It was reported through the litigation process that, sometime after the port placement, catheter kinking was noted in the subclavian region. However, there was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929891 ↗
• InjurySep 29, 2026Fracture; Material Separation; Obstruction of Flow; Malposition of Device; Blocked Connection; Material Deformation; Migration

  It was reported through the litigation process that, sometime after the port placement, the catheter allegedly occluded. Additionally, a catheter kink or hairpin turn deformity caused port dysfunction and difficulty accessing the port. The catheter was reported to have been positioned deep and nearly central in the chest with a sharp turn near the subclavian stick site. It was further reported that the port body was positioned excessively deep (almost to the chest wall) with a skewed orientation, resulting in difficulty with access and port dysfunction. Additionally, a catheter fragment allegedly migrated to an unknown location. The patient reportedly experienced pain radiating to the neck and left upper quadrant (LUQ). However, the current status of the patient was unknown.

  Patient problems: Pain

  MAUDE report 50929888 ↗
• InjurySep 29, 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 50929317 ↗
• InjurySep 29, 2026Device Appears to Trigger Rejection; Suction Problem; Obstruction of Flow

  It was reported through the litigation process that, sometime after the port placement, the device was nonfunctioning and experienced catheter malfunction, with an inability to aspirate blood and fibrin sheath formation extending over the catheter tip. Additionally, the patient developed catheter related thrombosis and occlusion due to blood clots within the catheter tubing. However, the current status of the patient was unknown.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50928871 ↗
• DeathSep 29, 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. It was further reported that the patient eventually expired. However, the cause of death was not reported.

  Patient problems: Unspecified Infection

  MAUDE report 50928870 ↗
• InjurySep 29, 2026Device Appears to Trigger Rejection; Obstruction of Flow; Blocked Connection

  It was reported through the litigation process that, sometime after the port placement, the device was nonfunctioning. The reported device malfunction was characterized by an inability to aspirate blood and fibrin sheath formation extending over the catheter tip. Additionally, the patient was diagnosed with catheter related thrombosis and occlusion, due to blood clots within the catheter tubing. However, the current status of the patient is unknown.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50928400 ↗
• InjurySep 29, 2026Device Appears to Trigger Rejection; Obstruction of Flow

  It was reported through the litigation process that, sometime after the port placement, the catheter, port body, and reservoir allegedly occluded. Additionally, port catheter dysfunction with clotting or occlusion resulted in a nonfunctioning port, and port dysfunction was reported. It was further reported that the patient was diagnosed with thrombosis. The port was subsequently removed. However, the current status of the patient was unknown.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50928167 ↗
• InjurySep 29, 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 50928108 ↗
• InjurySep 28, 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 50912812 ↗
• InjurySep 28, 2026Fluid/Blood Leak

  It was reported through the litigation process that, sometime after the port placement, the port allegedly leaked fluid during treatment. Additionally, the patient was diagnosed with an unspecified infection, pain, and cellulitis around the chemo port. However, the current status of the patient was unknown.

  Patient problems: Cellulitis; Pain; Unspecified Infection

  MAUDE report 50912639 ↗
• MalfunctionSep 28, 2026Fracture

  It was reported through the litigation process that, sometime after the port placement, the catheter allegedly fractured. However, there was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911652 ↗
• InjurySep 25, 2026Fracture; Material Separation; Migration

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50896667 ↗
• InjurySep 25, 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 remains unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50895901 ↗
• InjurySep 24, 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 50881340 ↗

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
• PowerPICC Provena116 models · 1,337 reports · 2 recalls
• PowerPort M.R.I., Groshong10 models · 1,285 reports
• Navarre15 models · 1,228 reports
• Navarre Opti-Drain8 models · 1,197 reports