Direxion HI-FLORecalls & reported problems across all models
Boston Scientific Corporation · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 9 models of Direxion HI-FLO by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between Jul 20, 2018 and May 13, 2026 — classified as 57 malfunctions.
The most frequently reported specific device problem is “Break” (25 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
Reports received per month, all models
Most reported Direxion HI-FLO problems
Device problems
- Break25
- Detachment of Device or Device Component12
- Fracture7
- Material Deformation6
- Physical Resistance/Sticking4
- Material Integrity Problem3
- Adverse Event Without Identified Device or Use Problem2
- Difficult to Remove2
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- No Consequences Or Impact To Patient18
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Direxion HI-FLO models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Direxion™ HI-FLO™ M001195440Catheter, continuous flush15 reports
- Direxion™ HI-FLO™ M001195450Catheter, continuous flush11 reports
- Direxion™ HI-FLO™ M001195410Catheter, continuous flush9 reports
- Direxion™ HI-FLO™ M001195420Catheter, continuous flush7 reports
- Direxion™ HI-FLO™ M001195500Catheter, continuous flush6 reports
- Direxion™ HI-FLO™ M001195470Catheter, continuous flush5 reports
- Direxion™ HI-FLO™ M001195430Catheter, continuous flush2 reports
- Direxion™ HI-FLO™ M001195490Catheter, continuous flush1 report
- Direxion™ HI-FLO™ M001195510Catheter, continuous flush1 report
Recent Direxion HI-FLO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Break; Difficult to Advance
IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 0.027IN SWAN TIP 130CM DIREXION? HI-FLO? MICROCATHETER WAS SELECTED FOR USE IN THE LIVER DURING A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION PROCEDURE. OUTSIDE THE PATIENT, WHEN THE MICROCATHETER WAS UNPACKED AND REMOVED FROM THE PACKAGING, IT FELT STIFF AND COULD NOT BE ADVANCED INTO THE RADIOGRAPHY CATHETER. THE MICROCATHETER WAS FOUND TO BE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162944 ↗MalfunctionMar 26, 2026Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, THERE WAS A LEAKAGE NOTED WHILE PRIMING THE LINE WITH WATER, AND THE CATHETER WAS ASSESSED TO BE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24706044 ↗MalfunctionFeb 24, 2026Degraded
IT WAS REPORTED THAT COATING ISSUE OCCURRED. A DIREXION HI-FLO CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER STRIPPED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434571 ↗MalfunctionAug 22, 2025Fracture; Fracture
IT WAS REPORTED VIA MEDWATCH # (B)(4) THAT A DEVICE BREAK OCCURRED. A DIREXION HI-FLO WAS SELECTED FOR USE. PRIOR TO PROCEDURE, IT WAS NOTED THAT THE WIRE WITHIN THE MICROCATHETER WAS FOUND BROKEN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22874301 ↗MalfunctionAug 11, 2025Nonstandard Device; Detachment of Device or Device Component; Material Integrity Problem; Nonstandard Device; Detachment of Device or Device Component; Material Integrity Problem
IT WAS REPORTED THAT TIP FRACTURE OCCURRED. A DIREXION HI-FLO MICROCATHETER WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). DURING THE PROCEDURE, IT WAS NOTED THAT THE ENTIRE TIP WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22778605 ↗MalfunctionJul 28, 2025Break
THE WIRE WITHIN MICROCATHETER WAS FOUND BROKEN DURING PREP OF THE CATHETER. THE CATHETER WAS REMOVED AND REPLACED WITH NO REPORTED HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR MICROCATHETER, 2.8FR DISTAL OD X 155CM DIREXION HI-FLO TORQUEABLE MICROCATHETER, BERN TIP, 0.02 (PER SITE REPORTER). MFG [MANUFACTURER] NOTIFIED BY SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22622806 ↗MalfunctionJul 22, 2025Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25JUN2025. IT WAS REPORTED THAT THE MICROCATHETER WAS BLOCKED. A DIREXION HI-FLO WAS SELECTED FOR USE IN A RIGHT THORACIC TUMOR AND BRONCHIAL ARTERY CHEMOEMBOLIZATION PROCEDURE. DURING PROCEDURE, THE MICROCATHETER WAS BLOCKED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE NICKEL SHAFT WAS FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22568351 ↗MalfunctionOct 21, 2024Fracture; Fracture
IT WAS REPORTED THAT MICROCATHETER FRACTURE OCCURRED. A SINGLE/027/STRAIGHT/1RO/155 DIREXION HI-FLO WAS SELECTED FOR LIVER CANCER TREATMENT. DURING THE PROCEDURE, IT WAS FOUND THAT THE MICROCATHETER WAS FRACTURED. THE DEVICE WAS REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE FRACTURE WAS ABOUT 5 TO 10CM FROM THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20495026 ↗MalfunctionJul 22, 2024Fracture; Fracture
IT WAS REPORTED THAT NICKEL SHAFT FRACTURE OCCURRED. A 027/STRAIGHT/1RO/155 DIREXION HI-FLO CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MICROCATHETER WAS IMPLANTED BUT COULDN'T BE ADVANCED AND WAS DISCOVERED TO BE BROKEN AROUND 0.2CM FROM THE HUB. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19799203 ↗MalfunctionJul 9, 2024
MIDDLE-AGED FEMALE WITH HISTORY OF UTERINE FIBROIDS AND BLEEDING. PROCEDURE: BILATERAL UTERINE ARTERY EMBOLISM PROCEDURE. SUPERIOR HYPOGASTRIC NERVE BLOCK. 500-700U EMBOSPHERES BEING PUSHED, AND THE CATHETER SEPARATED FROM THE HUB. CATHETER EXCHANGED WITHOUT FURTHER PROBLEM. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR CATHETER, CONTINUOUS FLUSH, DIREXION HI-FLO (PER SITE REPORTER), WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19700601 ↗MalfunctionMay 7, 2024Fracture; Material Deformation; Fracture; Material Deformation
IT WAS REPORTED THAT MICROCATHETER WAS FRACTURED. A DIREXION HI-FLO WAS SELECTED FOR USE IN A HEPATIC ARTERIAL INFUSION CHEMOTHERAPY. THE CATHETER WAS SUCCESSFULLY PLACED, AND PATIENT WAS INJECTED WITH CHEMOTHERAPY DRUGS. DURING NURSE'S WARD ROUND, THE PATIENT COMPLAINED THAT THERE WAS FLUID FLOWING OUT OF THE CATHETER ON THE RIGHT SIDE, AND IT WAS IMMEDIATELY CHECKED AND FOUND THAT THE MICROCATHETER WAS KINKED, 2ML OF BRIGHT RED BLOOD COULD BE SEEN FLOWING OUT THROUGH THE MICROCATHETER. A STERILE GAUZE WAS PRESSED AT THE PATIENT'S BLOODING END AND CLOSED THE INFUSION END. UPON CHECKING THE SPOT, IT WAS FOUND OUT THAT THE MICROCATHETER HAD CRACKS IN MANY PLACES AND COULD NOT BE USED ANYMORE. THE PHYSICIAN REMOVED THE MICROCATHETER AND ADJUSTED THE INFUSION OF CHEMOTHERAPY DRUGS THROUGH THE HEPATIC ARTERIAL CATHETER. THE PATIENT'S VITAL SIGNS WERE STABLE UNDER CONTINUOUS INFUSION ON THE SPOT AND THE PATIENT WAS DISCHARGED WITH NO COMPLICATIONS. THE DEVICE WAS DISPOSED AT THE FACILITY AND WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19264465 ↗MalfunctionMar 29, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component
IT WAS REPORTED THAT THE MICROCATHETER DETACHMENT OCCURRED. A DIREXION HI-FLO WAS SELECTED FOR USE IN A TRANSARTERIAL CHEMOEMBOLISATION (TACE) PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE MICROCATHETER BECAME STUCK AND RESISTANCE FELT WHEN THE CATHETER WAS REMOVED. THE DEVICE WAS REMOVED TOGETHER WITH THE NON-BOSTON SCIENTIFIC (BSC) IMAGING CATHETER, AND IT WAS NOTED THAT IT GOT SEPARATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19004655 ↗MalfunctionOct 12, 2023Fracture; Fracture
IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. A DIREXION HI-FLO MICROCATHETER WAS SELECTED FOR LEFT GASTRIC ARTERY EMBOLIZATION COMBINED WITH HEPATIC ARTERY EMBOLIZATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS FRACTURED INSIDE THE PATIENT'S BODY. THE DEVICE WAS SLOWLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17927059 ↗MalfunctionSep 28, 2023Break; Break
IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A DIREXION HI-FLO MICROCATHETER WAS SELECTED FOR TRANSCATHETER HEPATIC ARTERY EMBOLIZATION (TACE). DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT OF THE CATHETER WAS BROKEN. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17835290 ↗MalfunctionSep 25, 2023Fracture; Fracture
IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. THE 20% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LIVER. A NGMC/SINGLE/027/STRAIGHT/1RO/130 DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE FRACTURED ABOUT 37CM FROM THE HUB INSIDE THE BODY. THE DEVICE WAS REMOVED WITHOUT ANY ADDITIONAL INTERVENTION DONE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17811040 ↗
Other Boston Scientific Corporation products
- INGEVITY MRI7 models · 16,601 reports
- INGEVITY+3 models · 16,054 reports
- EMBLEM S-ICD4 models · 13,295 reports · 1 recall
- WATCHMAN25 models · 8,024 reports · 6 recalls
- AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
- ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
- RELIANCE 4-FRONT11 models · 5,739 reports
- FINELINE II EZ Sterox6 models · 5,633 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.
How reports and recalls are matched · Editorial policy · Report an error on this page