SafeStepRecalls & reported problems across all models

We found 7 models of SafeStep by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between May 4, 2018 and Dec 3, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

2 FDA recall records name at least one of these models by its device identifier.

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

SafeStep 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. Jun 19, 2020Terminated

   Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.

   Z-2667-2020 · Root cause: Process control · Recall details · FDA record ↗

2. Jun 19, 2020Terminated

   Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.

   Z-2665-2020 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

Most reported SafeStep problems

SafeStep models

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

• SafeStep CPA00020A

  Set, administration, intravascular
  1 recall0 reports
• SafeStep CPA00040

  Non-Coring (Huber) Needle
  1 recall0 reports
• SafeStep CPA00049

  Non-Coring (Huber) Needle
  1 recall0 reports
• SafeStep CPA00042A

  Non-Coring (Huber) Needle
  1 recall0 reports
• SafeStep CPA00010A

  Set, administration, intravascular
  1 report
• SafeStep CPA00019B

  Non-Coring (Huber) Needle
  1 report
• SafeStep CPA00040B

  Non-coring (Huber) needle
  1 report

Recent SafeStep adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THE CLEAR PLASTIC WAS BROKEN OFF OF A STERILE SALINE FLUSH SYRINGE WHEN THE PACKAGING WAS OPENED. THE STERILE SALINE FLUSH SYRINGE WAS INCLUDED WITH A CUSTOM PORT ACCESS KIT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704673 ↗
• MalfunctionMay 4, 2021Output Problem

  USED A KIT TO ACCESS PATIENT PORT AND CHLORHEXIDINE DID NOT RELEASE INTO SPONGE. THIS IS THE THIRD KIT I HAVE HAD PROBLEMS WITH CHLORHEXIDINE NOT RELEASING INTO SPONGES OVER THE PAST 1 WEEK.

  Patient problems: Insufficient Information

  MAUDE report 11769100 ↗
• MalfunctionMay 4, 2018Fluid/Blood Leak

  IT WAS REPORTED THE Y-SITE ON THE HUBER (THE INNER BLUE SEPTUM ON THE Y-SITE) LEAKED UPON INFUSION (NOT ACCESSED PRIOR TO).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7487707 ↗

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