DuoGlide catheterRecalls & reported problems across all models
Bard Access Systems, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one DuoGlide catheter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 2
We found 11 models of DuoGlide catheter by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 13 adverse event reports in the FDA's MAUDE database, received between Mar 30, 2016 and Sep 23, 2026 — classified as 2 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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
DuoGlide catheter 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.
- Aug 10, 2026Open, Classified
this is a downstream recall of class I recall RES 98777
Z-2985-2026 · Root cause: Material/Component Contamination · names 8 of these models · Recall details · FDA record ↗
- 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-2657-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported DuoGlide catheter problems
Device problems
- Fluid/Blood Leak4
- Break3
- Material Deformation3
- Kinked2
- Appropriate Device Problem Term/Code Not Available1
- Backflow1
- Device Contamination with Chemical or Other Material1
- Device Inoperable1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient3
- Hemorrhage/Blood Loss/Bleeding2
- No Known Impact Or Consequence To Patient2
- Coagulation Disorder1
- Foreign Body In Patient1
DuoGlide catheter models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DuoGlide catheter 5625240CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls1 report
- DuoGlide catheter 5625150CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall3 reports
- DuoGlide catheter 5626150CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall2 reports
- DuoGlide catheter 5625200CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall1 report
- DuoGlide catheter 5626200CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall1 report
- DuoGlide catheter 5625300CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall0 reports
- DuoGlide catheter 5626120CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall0 reports
- DuoGlide catheter 5626240CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall0 reports
- DuoGlide catheter 5623150CATHETER, HEMODIALYSIS, NON-IMPLANTED2 reports
- DuoGlide catheter 5624150CATHETER, HEMODIALYSIS, NON-IMPLANTED2 reports
- DuoGlide catheter 5624120CATHETER, HEMODIALYSIS, NON-IMPLANTED1 report
Recent DuoGlide catheter adverse event reports
The 13 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Break
It was reported by MedWatch temporary dialysis line port broke off (arterial/right/red port). The clamp came off as well with the distal port portion which caused the patient to bleed. This was identified by nursing and bleeding was controlled, clamp to stop bleeding. Line required replacement. No further information was provided.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50870561 ↗MalfunctionApr 16, 2026Fluid/Blood Leak
IT WAS REPORTED THE CLINICIAN NOTICED THAT AFTER THE VENOUS SIDE WAS FLUSHED AND CLAMPED, THE CATHETER STARTED TO BACK FILL. THE CLINICIAN THEN ASPIRATED, FLUSHED WITH SALINE, RE-FLUSHED WITH HEPARIN AND RE-CLAMPED THE CATHETER. AFTER ALL OF THAT, THE CLINICIAN NOTICED THAT THE CATHETER WAS STILL BACKFILLING. LATER IT WAS NOTED THAT SOME SALINE WAS ON THE PATIENT SHIRT, AND THAT LOOKED AS IF IT HAD LEAKED AND CAUSED THEM TO INSPECT THE LINE CLOSER. ON CLOSER INSPECTION, THE VENOUS LUMEN HAD SMALL HOLE THAT THEY COULD SEE LEAKING BLOOD. NO INJURIES OR SERIOUS EVENT RESULTED DUE TO THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896735 ↗MalfunctionMar 3, 2026Fluid/Blood Leak
IT WAS REPORTED PATIENT HAD THIS LINE PLACED IN THE RT IJ. AFTER THE LINE WAS LOCKED, THE PROVIDER NOTED THAT IT WAS BACK FILLING WITH BLOOD. CONCERNED FOR A LEAK, THE PROVIDER REPLACED THE LINE INTRAPROCEDURAL PRIOR TO SUTURING IN PLACE. THE NEW LINE APPEARED TO BE INTACT. DURING THE PATIENT'S TREATMENT AFTER THE PLACEMENT, WE WERE CONTACTED BY THE TEAM BECAUSE THE LINE WAS LEAKING. THE PATIENT WAS AGAIN BROUGHT TO THE IR DEPARTMENT AND A 3RD LINE WAS PLACED FROM A DIFFERENT LOT NUMBER AND WAS SUCCESSFUL. DELAY IN TREATMENT PLAN BY APPROXIMATELY 24HOURS. OVERNIGHT STAY WAS REQUIRED TO ENSURE TIMING OF TREATMENT TO PREVENT A 3 MONTH DELAY FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES BOTH DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500448 ↗MalfunctionFeb 11, 2025Material Deformation; Material Deformation
IT WAS REPORTED LINE WAS PLACED (B)(6). ON (B)(6) THEY REPORTED ISSUE WITH THE LINE. X-RAY WAS DONE AND IT SHOWED THE TIP OF THE PICC BEING LOOPED IN THE AZYGOS. NO PATIENT HARM WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21361023 ↗MalfunctionMay 20, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER, THERE WAS A MICRO-CRACK JUST BEFORE THE PLASTIC LUMEN BEGINS AND WASN'T DISCOVERED UNTIL BEDSIDE CRRT WAS TURNED ON AND THE PRESSURE BEGAN. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19356178 ↗MalfunctionFeb 23, 2024Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak
IT WAS REPORTED NURSE NOTIFIED DR THAT HD CATHETER SITE HAVING CONTINUOUS BLEEDING, MULTIPLE ATTEMPTS MADE TO STOP BLEEDING, DRESSING CHANGED THIS AM AND PRESSURE DRESSING APPLIED. DR ASSESSED AREA AND THEN DRESSING CHANGED AT 1400 GELFOAM, PRESSURE DRESSING AND ALLEVYN APPLIED AT THAT TIME. AT 1600 DRESSING WAS SATURATED AND DR AT BESIDE ASSESSED SITE. IT WAS DETERMINED THAT THE BLEEDING WAS FROM THE CATHETER NOT THE CATHETER INSERTION SITE. DR REMOVED THE HD CATHETER. AFTER REMOVAL OF CATHETER DR DETERMINED THAT POSSIBLE VASCULAR TISSUE PROTRUDING FROM INSERTION SITE. PRESSURE HELD AT SITE BY THE RN, DR IN CONTACT WITH VASCULAR SURGERY DEPARTMENT AT HOSPITAL. PATIENT VITAL SIGNS REMAIN STABLE, PATIENT¿S HUSBAND AT BEDSIDE AND AWARE OF PLANS AT THIS TIME. NO HARM TO THE PATIENT OTHER THAN THE PROCEDURE/PAIN IT CAUSED OF BEING INSERTED, BEING OF NO USE, AND HAVING TO TAKE IT OUT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18767941 ↗InjuryOct 4, 2022Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT THE "CATHETER STOPPED WORKING IN THE MIDDLE OF THE SURGERY AT THE END OF THE CASE WHILE REMOVING IT THE TEAM NOTICED THAT PART OF IT IS MISSING DONE X RAY AND FOUND THE PIECE OF REMAINING CATHETER RETAINED IN THE HEART THE PRODUCT REMOVED AND SEND TO PATHOLOGY WITH A NEW CATHETER TO COMPARE THE DEVICE."
Patient problems: Foreign Body In Patient
MAUDE report 15540817 ↗MalfunctionOct 29, 2020Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE CURVED EXTENSION LEGS ARE PULLING ON THE INSERTION SITE AND CAUSING THE DRESSINGS TO LIFT OFF OF THE SKIN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10759342 ↗MalfunctionJun 11, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHEN ONE OF OUR INTENSIVISTS OPENED THE KIT TO PLACE THE LINE, HE FOUND A LARGE STRAND OF HAIR PACKAGED IN THE STERILE SUPPLIES. THE KIT WAS NOT UTILIZED AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10146024 ↗InjuryFeb 17, 2017Device Operates Differently Than Expected
FACILITY REPORTED TO THE SALES REPRESENTATIVE THAT WHEN THE PRODUCT WAS INSERTED, IT APPEARED TO BE STIFF BUT BECAME SOFT AND FLIMSY DURING INSERTION WHICH CREATED DIFFICULTY WITH PLACEMENT. THIS CAUSED CLOTTING IN USING THIS DEVICE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. NO PATIENT INJURY REPORTED.
Patient problems: Coagulation Disorder
MAUDE report 6341395 ↗MalfunctionDec 21, 2016Break; Kinked; Material Deformation
PER SALES REPRESENTATIVE, THE ICU DEPARTMENT REPORTED THEY HAD A GUIDEWIRE ISSUE WITH A "DUAL GLIDE". NO ADDITIONAL INFORMATION PROVIDED WHEN REQUESTED. ON (B)(6) 2016 - PER ENGINEERING TECH, THE SAMPLE GUIDEWIRE RECEIVED FOR THIS FILE WAS STRETCHED, KINKED AND BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6197238 ↗MalfunctionOct 20, 2016Material Deformation
AS REPORTED BY THE FACILITY VIA MEDWATCH, "DR. WAS PLACING TEMP HD CATHETER ON PATIENT. WHILE ATTEMPTING TO REMOVE THE GUIDEWIRE IT WAS NOTED THE GUIDEWIRE HAD UNRAVELED AND BECAME FLIMSY. WIRE STILL CONNECTED TO TIP AND REMOVED COMPLETELY. NO HARM TO PATIENT."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6045418 ↗MalfunctionMar 30, 2016Kinked; Device Inoperable
IT WAS REPORTED THAT THE EXTENSION ON THE 15CM DUOGLIDE KINKED/COLLAPSED DURING CRRT. THE LINE WAS POSITIONED IN THE JUGULAR AND WHEN IT WAS HOOKED UP FOR "CONTINUOUS", A MEMORY IN THE CLEAR EXTENSION PORTION OF THE CATHETER REPORTEDLY BECAME EXTREMELY SOFT AND RESULTED IN THE MACHINE STOPPING. IT WAS REPORTED THAT THE MACHINE USUALLY RUNS UP TO 300 BUT COULD ONLY ACHIEVE 200-250. THE LINE STOPPED WORKING ALTOGETHER AND A NEW LINE WAS REQUIRED. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5536719 ↗
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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