PowerMidlineRecalls & reported problems across all models
Bard Access Systems, Inc. · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one PowerMidline model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 1
We found 15 models of PowerMidline by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between May 10, 2019 and Jul 31, 2026 — classified as 6 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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
Reports received per month, all models
PowerMidline 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.
- May 21, 2026Open, Classified
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2662-2026 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗
Most reported PowerMidline problems
Device problems
- Fluid/Blood Leak9
- Material Deformation9
- Defective Component8
- Break5
- Detachment of Device or Device Component4
- Difficult or Delayed Separation4
- Contamination /Decontamination Problem3
- Difficult to Insert3
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Consequences Or Impact To Patient8
- Foreign Body In Patient5
- Pain2
- Device Embedded In Tissue or Plaque1
- Hematoma1
- Hemorrhage/Blood Loss/Bleeding1
- Laceration(s)1
PowerMidline models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PowerMidline CK000727Midline catheter1 recall5 reports
- PowerMidline CK000729Midline catheter1 recall4 reports
- PowerMidline CK000799AMidline catheter7 reports
- PowerMidline CK000756Midline catheter6 reports
- PowerMidline CK000805Midline catheter4 reports
- PowerMidline CK000856Midline catheter4 reports
- PowerMidline CK000799Midline catheter3 reports
- PowerMidline CK000908Midline catheter2 reports
- PowerMidline CK000912AMidline catheter2 reports
- PowerMidline CK001029Midline catheter2 reports
- PowerMidline PP4154108DCPMidline catheter2 reports
- PowerMidline CK000523BMidline catheter1 report
- PowerMidline CK000798Midline catheter1 report
- PowerMidline CK000860Midline catheter1 report
- PowerMidline CK000910Midline catheter1 report
Recent PowerMidline adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099432 ↗MalfunctionMay 28, 2026Fluid/Blood Leak
IT WAS REPORTED NOTICED THAT IT WAS LEAKING AT THE INSERTION SITE AFTER A COUPLE OF DAYS AND HAD TO PULL THE LINE. CATHETER WAS REPLACED. THERE WAS NO PATIENT SYMPTOMS RELATED TO THE LEAK. THE CATHETER WAS SECURED WITH GLUE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25318300 ↗MalfunctionMar 17, 2026Material Deformation
IT WAS REPORTED THREE BARD SL POWER KITS WHERE THE TOP OF THE GRAY SHEATH OF THE INTRODUCER HAS A SMALL SPLIT APPROXIMATELY 1 CM IN LENGTH. THIS IS BEFORE USE. THERE WAS NO NEGATIVE OUTCOME THAT OCCURRED AS A RESULT. THIS REPORT ADDRESSES ALL THREE KITS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617548 ↗MalfunctionMar 17, 2026Material Deformation
IT WAS REPORTED BARD SL POWER KIT WHERE THE TOP OF THE GRAY SHEATH OF THE INTRODUCER HAS A SMALL SPLIT APPROXIMATELY 1 CM IN LENGTH. THIS IS BEFORE USE. I NOTICED THE SPLIT UPON INSERTION WITH VERY LITTLE FORCE. NO NEGATIVE OUTCOME OCCURRED AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617536 ↗InjuryMar 16, 2026Product Quality Problem; Difficult to Remove
IT WAS REPORTED VIA MEDWATCH THAT AFTER INSERTING NEEDLE INTO VESSEL WITH BLOOD RETURN, UNABLE TO ADVANCE WIRE. NEEDLE REMOVED OVER WIRE. UNABLE TO REMOVE WIRE. NO FURTHER DETAILS PROVIDED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24606301 ↗MalfunctionMar 2, 2026Material Deformation
IT WAS REPORTED A DEFECTIVE SHEATH IN A MIDLINE KIT THIS WEEKEND. THERE WAS NO INJURY, THE KIT WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24489452 ↗MalfunctionDec 10, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
ADDITIONAL INFORMATION: DEVICE WAS REMOVED AND REPLACED BY A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23768966 ↗MalfunctionNov 18, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED NURSE HAD A LOT OF DIFFICULTY REMOVING STYLET AS THE "T" CONNECTOR WOULD NOT SEPARATE FROM THE MIDLINE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584394 ↗MalfunctionOct 29, 2025Product Quality Problem; Tear, Rip or Hole in Device Packaging; Product Quality Problem; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED BY CUSTOMER THAT THE PROBE COVER RIPPED, NOTICED POST PROCEDURE. NO FURTHER DETAILS AVAILABLE OR PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23415222 ↗MalfunctionJun 20, 2025Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED, HAD AN ISSUE WHEN PLACING A MIDLINE AND THE DILATOR NOT PEELING AWAY CORRECTLY. ADDITIONAL INFORMATION PROVIDED 09-JUNE-2025: THE CATHETER WAS STILL ATTACHED BY A THIN RING OF PLASTIC ON ONE SIDE OF THE DILATOR. IT TOOK A LOT OF PRESSURE TO BREAK THIS PLASTIC CIRCLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22301629 ↗MalfunctionJun 3, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THERE HAVE BEEN SEVERAL REPORTS OF FIBERS ON THE WIRE. THE EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22132944 ↗MalfunctionApr 30, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED BY THE CUSTOMER THE NEEDLE HAS BLACK SPECS INSIDE THE HUB. THIS NEEDLE WAS OPENED BEFORE THE SPECS WERE DISCOVERED BUT WAS NOT USED ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21940323 ↗MalfunctionApr 30, 2025Activation Problem; Activation Problem
IT WAS REPORTED BY THE CUSTOMER WHEN SLIDING THE SAFETY INTO PLACE ON THE NEEDLE, THE SAFETY SLIDES ALL THE WAY OFF THE NEEDLE AND DETACHES FROM THE NEEDLE. THE NEEDLE REMAINS OPEN AND UNSAFE. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT OR HEALTHCARE PROFESSIONAL. IT WAS REPORTED THIS OCCURRED WITH NINE DEVICES. THIS REPORT ADDRESSES ALL NINE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21938740 ↗MalfunctionApr 30, 2025Activation Problem; Activation Problem
IT WAS REPORTED BY THE CUSTOMER WHEN SLIDING THE SAFETY INTO PLACE ON THE NEEDLE, THE SAFETY SLIDES ALL THE WAY OFF THE NEEDLE AND DETACHES FROM THE NEEDLE. THE NEEDLE REMAINS OPEN AND UNSAFE. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT OR HEALTHCARE PROFESSIONAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21938707 ↗MalfunctionApr 17, 2025Defective Component; Defective Component
IT WAS REPORTED "I WAS PLACING A MIDLINE TODAY AND NOTICED A WEIRD SPIRALING ON THE INTERNAL WIRE FOR THE POWER MIDLINE. WHEN I PULLED THE WIRE OUT OF THE MIDLINE AFTER THE MIDLINE WAS PLACED, I NOTICED FRAYING ON THE WIRE ITSELF. YOU CAN SEE SOME SMALL WHITE SPECKS AND FRAYS. I THEN NOTICED IT ON MY SECOND MIDLINE OF THE DAY. A COLLEGE ASKED ME IF I WOULD BE ABLE TO PULL ANY OF THOSE PIECES OFF IF I GRABBED ON TO THEM. I TRIED THIS AFTER AND I HAD ONE THAT FLAKED OFF RIGHT IN MY HAND. JUST LOOKED LIKE A LITTLE WHITE SPECK. THE FRAYING DOES GET WORSE IF YOU RUN YOUR FINGERS ACROSS IT., IT'S WAY MORE NOTICEABLE AT THAT POINT. THERE WAS NO ADVERSE EVENT DURING OR AFTER THE PROCEDURE." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES BOTH DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21858491 ↗
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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