PowerLocRecalls & reported problems across all models

We found 16 models of PowerLoc by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Apr 24, 2018 and Sep 30, 2026 — classified as 1 injury, 52 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 reports).

1 FDA recall record 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

PowerLoc 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-2661-2020 · Root cause: Process control · names 5 of these models · Recall details · FDA record ↗

Most reported PowerLoc problems

PowerLoc models

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

• PowerLoc CPA00028

  Set, administration, intravascular
  1 recall0 reports
• PowerLoc CPA00032

  Set, administration, intravascular
  1 recall0 reports
• PowerLoc CPA00036

  Set, administration, intravascular
  1 recall0 reports
• PowerLoc CPA00051

  Set, administration, intravascular
  1 recall0 reports
• PowerLoc CPA00055

  Set, administration, intravascular
  1 recall0 reports
• PowerLoc 0672034J

  Set, administration, intravascular
  18 reports
• PowerLoc 0671934J

  Set, administration, intravascular
  9 reports
• PowerLoc CPA00052

  Set, administration, intravascular
  9 reports
• PowerLoc 8652234

  Set, administration, intravascular
  6 reports
• PowerLoc 8652010

  Set, administration, intravascular
  4 reports
• PowerLoc CPA00029

  Set, administration, intravascular
  2 reports
• PowerLoc 8651934

  Set, administration, intravascular
  1 report
• PowerLoc 8671934

  Set, administration, intravascular
  1 report
• PowerLoc 8672010

  Set, administration, intravascular
  1 report
• PowerLoc CPA00050

  Set, administration, intravascular
  1 report
• PowerLoc CPA00058

  Set, administration, intravascular
  1 report

Recent PowerLoc adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  It was reported a single use implantable drug delivery device with a port needle was connected for a patient on September 8. On September 10, during the infusion, fluid leakage was discovered at the connection between the port needle and the tubing, so a new port needle was used for the puncture. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941954 ↗
• MalfunctionAug 7, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50177249 ↗
• MalfunctionJul 9, 2026Product Quality Problem

  Patient problems: Discomfort

  MAUDE report 25764163 ↗
• MalfunctionMay 5, 2026Fluid/Blood Leak

  IT WAS REPORTED ON (B)(6) 2026 THE CLINICIAN PLACED THE CANNULA, AND WHEN THE INFUSION PORT WAS INSERTED TO SEAL THE TUBING, IT WAS FOUND TO BE LEAKING AT THE YELLOW BUTTERFLY PLANE WING OF THE INFUSION PORT NEEDLE, BUT THE PHENOMENON WAS NOT FOUND WHEN THE INFUSION PORT NEEDLE WAS IN THE PRE-FLUSH TUBING. IMMEDIATELY REPLACED THE NEW IMPLANTED PORT CANNULA, THE NEW IMPLANTED PORT NEEDLE FOR THE SAME COMPANY DIFFERENT MODELS OF PRODUCTS. BECAUSE THE PATIENT'S IMPLANTED PORT IS DEEPER, THE INFUSION PORT NEEDLE USED AT THE BEGINNING WAS LONGER, AND IT WAS FOUND THAT THE LONG NEEDLE WAS INSERTED WITH A LONG CUT AND THE LONG NEEDLE HAD LEAKAGE, AND THEN IT WAS REPLACED WITH A SHORT NEEDLE, AND IT WAS FOUND THAT IT WAS ALSO OK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25087485 ↗
• MalfunctionNov 25, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT WHEN THE NURSE WAS MAINTAINING THE PATIENT'S INFUSION PORT, THE WHITE CLIP DETACHED DIRECTLY AND COVERED THE NEEDLE TIP UPON REMOVING THE CAP FROM THE SINGLE-USE IMPLANTABLE DRUG DELIVERY DEVICE (INDWELLING NEEDLE), RENDERING THE INDWELLING NEEDLE UNUSABLE. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647865 ↗
• MalfunctionNov 4, 2025Contamination /Decontamination Problem; No Apparent Adverse Event; Contamination /Decontamination Problem; No Apparent Adverse Event

  IT WAS REPORTED UPON OPENING, FOREIGN MATTER SUCH AS CARDBOARD FRAGMENTS WAS FOUND. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469659 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TWO DEVICES HAD LEAKAGE DURING INFUSION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285844 ↗
• MalfunctionAug 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED ON 8/29/2025: THE EVENT WAS DISCOVERED WHEN PREPARING THE PORT NEEDLE TO INSERT IN THE PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909437 ↗
• MalfunctionJul 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THE NEEDLES APPEAR TO BE INTACT AND THERE IS NO OBVIOUS FAULT. HOWEVER, WHEN FLUSHING THEY ARE LEAKING FROM BEHIND THE NEEDLE. IT APPEARS THE FAULT IS BETWEEN THE YELLOW GRIPPER AND THE NEEDLE. THERE WAS NO HARM OR MEDICAL INTERVENTION REQUIRED, ONCE FAULT WAS IDENTIFIED BEFORE BEING USED AND ANOTHER HUBER NEEDLE WAS USED IMMEDIATELY. IT WAS REPORTED THIS OCCURRED WITH SIX DEVICES. THIS REPORT ADDRESSES ALL SIX DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370920 ↗
• MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, INFUSION HUBER NEEDLES ARE LEAKING. NOTICED THIS IN THE NEEDLE PRIMING STAGE AND NO PATIENTS HAVE BEEN AFFECTED. THE NEEDLES APPEAR TO BE INTACT AND THERE IS NO OBVIOUS FAULT. HOWEVER, WHEN FLUSHING THEY ARE LEAKING FROM BEHIND THE NEEDLE. IT APPEARS THE FAULT IS BETWEEN THE YELLOW GRIPPER AND THE NEEDLE. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320065 ↗
• MalfunctionJun 2, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED, USER OBSERVED FLUID LEAKAGE POST PET SCAN. SCAN WAS RUN AT 2ML ONLY BUT POWERLOC INDICATED MAX 5ML/S FLOW RATE. NO HIGH PRESSURE WAS TRIGGERED DURING INJECTION. TUBING HAD NO ISSUES BEFORE THE SCAN. PATIENT NOT IMPACTED AND NO COURSE OF TREATMENT CHANGED AS END USER ONLY NOTICED THE LEAKING AFTER THE SCAN COMPLETED. HOWEVER, END USER DID MENTION THAT THE SCAN TOOK LONGER TIME TO COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127480 ↗
• InjuryMay 15, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2025, WHEN MEDICAL STAFF USED A DISPOSABLE IMPLANTABLE DRUG DELIVERY CANNULA TO ADMINISTER INFUSION THERAPY TO A PATIENT, THE NEEDLE MALFUNCTIONED AND THE PUNCTURE FAILED. THEY IMMEDIATELY REPLACED THE NEEDLE WITH A NEW ONE AND PERFORMED A SECOND PUNCTURE, CAUSING SERIOUS INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22032449 ↗
• MalfunctionMay 12, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE CUSTOMER "TRANSFUSED A PATIENT'S TREATMENT WITHOUT ISSUE HOWEVER ON DISCONNECTING AND FLUSHING THE LINE IT BLOCKED. MYSELF AND TWO OTHER NURSES ASSESSED THE PATIENT AND THE NEEDLE, ULTIMATELY REMOVING IT. WE TRIED TO FLUSH IT WHEN IT WAS OUT OF THE PATIENT AND IT REALLY WOULDN'T LET US, IT WAS TOTALLY BLOCKED. WE RE-ACCESSED THE PATIENT WITH A NEW NEEDLE AND FLUSHED THE PORT WITHOUT ISSUE, PROVIDING IT WAS NOT THE PORT THAT WAS A PROBLEM." (B)(6) 2025 - DURING EVALUATION, A SMALL GREY MATERIAL WAS FOUND WITHIN THE TUBING OF THE INFUSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007053 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER, AFTER THE CUSTOMER REMOVED THE HARBOR PIN FROM THE PACKAGE, HE FOUND THAT THE EXTENSION TUBING WAS SEPARATED FROM THE INTERFACE PART. CANNOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21327487 ↗
• MalfunctionNov 20, 2024Failure to Infuse; Detachment of Device or Device Component; Failure to Infuse; Detachment of Device or Device Component

  IT WAS REPORTED, WHEN UNPACKING THE IMPLANTED PORT NEEDLES, ONE CASE COULD NOT BE PRIMED WITH FLUID. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20734027 ↗

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