Poly RadPICC CatheterRecalls & reported problems across all models
Bard Access Systems, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 65
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 6 models of Poly RadPICC Catheter by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Dec 4, 2015 and Jan 28, 2023 — classified as 3 injuries, 62 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (54 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. 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
Most reported Poly RadPICC Catheter problems
Device problems
- Detachment of Device or Device Component54
- Break3
- Adverse Event Without Identified Device or Use Problem2
- Crack1
- Defective Component1
- Device Operates Differently Than Expected1
- Difficult to Remove1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- No Known Impact Or Consequence To Patient8
- Unspecified Infection2
- No Information1
Poly RadPICC Catheter models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Poly RadPICC Catheter 3164155Catheter,intravascular,therapeutic,long-term greater than 30 days54 reports
- Poly RadPICC Catheter 3264155Catheter,intravascular,therapeutic,long-term greater than 30 days4 reports
- Poly RadPICC Catheter 3265135Catheter,intravascular,therapeutic,long-term greater than 30 days4 reports
- Poly RadPICC Catheter 3165135Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Poly RadPICC Catheter 3265155Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Poly RadPICC Catheter 3266135Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
Recent Poly RadPICC Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FORTY THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261353 ↗MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." ON 1/27/2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE THIRTY SIXTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261349 ↗MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE TWENTY NINETH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261344 ↗MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FORTY FIFTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261343 ↗MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE TWENTY SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261338 ↗MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM.". 1/27/2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE THIRTY EIGHTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261337 ↗MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FIFTEENTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261334 ↗MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE THIRTY FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261333 ↗MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE EIGHTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261329 ↗MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." 1/27/2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE TWENTY FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261328 ↗MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." 1/27/2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FORTY EIGHTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261323 ↗MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." 1/27/2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE SEVENTEENTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261322 ↗MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FORTY FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261321 ↗MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." 1/27/2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE TENTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261319 ↗MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FORTY SIXTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261318 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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