AngioDynamicsRecalls & reported problems across all models
Navilyst Medical, Inc. · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 119
- Deaths reported
- 17
- Injuries reported
- 52
- Recalls
- 0
We found 16 models of AngioDynamics by Navilyst Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 119 adverse event reports in the FDA's MAUDE database, received between Apr 20, 2016 and Jun 26, 2026 — classified as 17 deaths, 52 injuries, 50 malfunctions.
The most frequently reported specific device problem is “Fracture” (47 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 AngioDynamics problems
Device problems
- Fracture47
- Detachment of Device or Device Component28
- Adverse Event Without Identified Device or Use Problem27
- Crack7
- Break4
- Difficult to Remove3
- Material Fragmentation3
- Migration or Expulsion of Device3
Patient problems
- Device Embedded In Tissue or Plaque32
- Foreign Body In Patient28
- Death16
- No Clinical Signs, Symptoms or Conditions16
- No Known Impact Or Consequence To Patient9
- Cardiac Arrest7
- Pulmonary Embolism7
- Patient Problem/Medical Problem3
AngioDynamics models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AngioDynamics 25186CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS16 deaths31 reports
- AngioDynamics 45759DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION24 reports
- AngioDynamics 45753DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION18 reports
- AngioDynamics 45750DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION14 reports
- AngioDynamics 45756DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION5 reports
- AngioDynamics 25185CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 death4 reports
- AngioDynamics 45748DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION4 reports
- AngioDynamics 45752DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION4 reports
- AngioDynamics 45754DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION4 reports
- AngioDynamics 45749DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION3 reports
- AngioDynamics 45751DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION3 reports
- AngioDynamics 25184CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
- AngioDynamics 45755DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- AngioDynamics 45758DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- AngioDynamics 45785DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- 1 report
Recent AngioDynamics adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2026Adverse Event Without Identified Device or Use Problem
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75". IT WAS REPORTED THAT THERE HAVE BEEN SEVERAL CASES IN WHICH THERE WAS VESSEL INJURY DURING INSERTION. ADDITIONALLY, IT WAS REPORTED THAT AT THIS STAGE, THEY WERE UNABLE TO DETERMINE WHETHER THESE INCIDENTS WERE RELATED TO THE ITEM ITSELF OR TO PROCEDURAL AND USER-RELATED FACTORS. IT HAS BEEN DECIDED IN THE RADIOLOGY DEPARTMENT FOR THE ITEM TO BE USED ON THE VEIN AND NOT THE ARTERY.
Patient problems: Perforation of Vessels
MAUDE report 25634691 ↗MalfunctionMay 6, 2026Fracture; Detachment of Device or Device Component
ANGIODYNAMICS RECEIVED NOTIFICATION OF AN EVENT THAT AN END USER EXPERIENCED WITH A MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU ECHO 2.75". DURING A PROCEDURE, A PORTION OF THE SHEATH CANNULA BROKE OFF INSIDE THE PATIENT PRIOR TO THE EXCHANGE OF THE 9FR SHEATH. ATTEMPTS WERE MADE TO RETRIEVE THE TRANSLUCENT PIECE WITH A SNARE. HOSPITALIZATION WAS NEEDED DUE TO THIS EVENT. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: Foreign Body In Patient
MAUDE report 25096737 ↗MalfunctionMay 6, 2026Fracture; Detachment of Device or Device Component
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU ECHO 2.75. DURING WITHDRAWAL AFTER AN ULTRASOUND GUIDED ACCESS TO THE RIGHT INTERNAL JUGULAR, THE COAXIAL INTRODUCER STIFFENER SHEATH DISCONNECTED FROM THE HUB, LEAVING A SMALL PART OF THE MICROPUNCTURE INTRODUCER INSIDE THE PATIENT. THE ENTIRE RETAINED PORTION OF THE DILATOR/STIFFENER WAS REMOVED. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 25096722 ↗MalfunctionMay 6, 2026Fracture; Detachment of Device or Device Component
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75". DURING A PROCEDURE, THE DISTAL END OF THE CATHETER OF THE MICROPUNCTURE BROKE OFF INTO THE VEIN OF THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: Foreign Body In Patient
MAUDE report 25096719 ↗MalfunctionMay 6, 2026Fracture; Detachment of Device or Device Component
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75". DURING A PROCEDURE, THE DISTAL END OF THE CATHETER OF THE MICROPUNCTURE BROKE OFF INTO THE VEIN OF THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: Foreign Body In Patient
MAUDE report 25096718 ↗MalfunctionMar 5, 2026Fracture; Detachment of Device or Device Component
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU ECHO 2.75" KIT. IT WAS REPORTED THE SHEATH BROKE INTO TWO SEPARATE PIECES WHILE INSIDE THE PATIENT DURING TREATMENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 24517791 ↗MalfunctionFeb 4, 2026Fracture; Detachment of Device or Device Component
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75". DURING A CARDIAC PROCEDURE, WHILE THE SHEATH WAS INSIDE THE PATIENT, THE HUB OF THE SHEATH DETACHED CAUSING THE WHITE PORTION OF THE SHEATH TO REMAIN INSIDE OF THE PATIENT. VASCULAR SURGERY WAS CALLED TO ASSIST IN RETRIEVING THE SHEATH FROM THE PERIPHERAL VASCULAR SYSTEM. THE PROCEDURE WAS COMPLETED AFTER RETRIEVAL OF THE SHEATH. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 24261737 ↗MalfunctionJan 19, 2026Fracture; Detachment of Device or Device Component
ANGIODYNAMICS RECEIVED NOTIFICATION OF AN EVENT FROM THE FDA REGARDING A MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75". DURING AN ARTERIAL LINE PLACEMENT PROCEDURE, WHILE ATTEMPTING TO REMOVE THE GUIDEWIRE, THERE WAS RESISTANCE MET. UPON WITHDRAWAL, IT WAS NOTED THE WIRE HAD BROKEN OFF INSIDE OF THE PATIENT. X-RAY WAS CALLED, AND IT WAS DETERMINED THAT APPROXIMATELY 19MM OF THE WIRE WAS RETAINED IN THE RIGHT ANTERLATERAL ASPECT OF THE DISTAL FOREARM. SURGERY WAS CONSULTED AND A CT WAS PERFORMED TO SEE IF THE BROKEN LINE WAS VENOUS OR ARTERIAL. WHILE WAITING FOR THE CT RESULTS THE BROKEN WIRE WAS COMPARED TO A KNOWN GOOD WIRE TO DETERMINE THE LENGTH OF THE RETAINED WIRE FRAGMENT. AN ATTEMPT TO REMOVE THE FRAGMENT WAS MADE BUT WAS UNSUCCESSFUL. THE PATIENT IS SCHEDULED FOR ON (B)(6) 2026 FOR SURGICAL REMOVAL OF THE RETAINED GUIDEWIRE FRAGMENT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 24109470 ↗MalfunctionDec 3, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
ANGIODYNAMICS RECEIVED NOTIFICATION OF AN EVENT FROM THE FDA REGARDING A MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75". A PATIENT WITH A DIAGNOSIS OF ATHEROSCLEROSIS OF THE LEFT LOWER EXTREMITY WITH FIRST TOE ULCERATION WAS ADMITTED FOR A LEFT TRANSPOPLITEAL SUPERFICAL FEMORAL ARTERY INTERVENTION. A COAXIAL MICROINTRODUCER (MINI STICK MAX) WAS USED IN THE PROCEDURE. DURING THE PROCEDURE, A PORTION (7.62CM) OF THE CATHETER [SHEATH TUBING] BROKE OFF AND BECAME LODGED IN THE TISSUE SURROUNDING THE ARTERY. THE OBJECT COULD NOT BE REMOVED WITHOUT A SURGICAL PROCEDURE. THE PATIENT ELECTED TO NOT HAVE THE OBJECT REMOVED.
Patient problems: Infiltration into Tissue
MAUDE report 23708331 ↗MalfunctionDec 3, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
AN END USER REPORTED AN ISSUE WITH A MINI STICK MAX COAXIAL MICROINTRODUCER KIT 4FR. THE MINI STICK MAX KIT (21G NEEDLE, 0.018" MICRO WIRE) USED FOR THE INITIAL ACCESS TO THE RIGHT INTERNAL JUGULAR (RIJ) USING SONOGRAPHIC FLOUROSCOPE GUIDANCE AND LOCAL ANESTHESIA. WHEN ADVANCING THE GUIDEWIRE, RESISTANCE WAS MET AND IT WAS NOTED THE WIRE WAS LIKELY ENTRAPPED IN THE VESSEL INTIMA. THE WIRE AND THE NEEDLE WERE WITHDRAWN AS ONE UNIT, HOWEVER, DURING WITHDRAWAL, THE DISTAL END OF THE WIRE (1MM) REMAINED STUCK INSIDE OF THE SUBCUTANEOUS (SQ) TISSUE. THERE WAS NO EVIDENCE OF VESSEL INJURY. DURING THE WIRE REMOVAL ATTEMPT, THE DISTAL END OF THE WIRE WAS STRIPPED. WITH ASSISTANCE FROM A SECOND PROCEDURALIST, THEY WERE ABLE TO REMOVE THE MAJORITY OF THE WIRE. THERE WAS A RETAINED FRAGMENT VISUALIZED IN THE SQ TISSUE UNDER FLOUROSCOPY, WHICH WAS RETRIEVED WITH FORCEPS AFTER MAKING A SMALL SKIN INCISION AND BLUNT DISSECTION OF THE SQ TISSUE. ANOTHER NEEDLE AND A 0.35"JWIRE WERE USED FOR ACCESS AND AN INTRODUCER SHEATH AND PULMONARY ARTERY (PA) CATHETER WERE PLACED WITHOUT FURTHER COMPLICATIONS.
Patient problems: Infiltration into Tissue
MAUDE report 23708330 ↗MalfunctionSep 2, 2025Fracture; Fracture
AN END USER REPORTED AN ISSUE WITH A MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75". THE PATIENT HAD A MECHANICAL THROMBECTOMY. IT WAS NOTED THERE WAS A MICRODILATOR FRACTURE INTRAPROCEDURE. IT WAS NOTED THE MICRODILATOR WAS ADVANCED OVER THE MICROWIRE AFTER WHICH THE MICROWIRE AND THE INNER DILATOR WERE REMOVED. A J-WIRE WAS ADVANCED THROUGH THE MICRODILATOR [COAXIAL SHEATH] AND THEN THE DILATOR [COAXIAL SHEATH] WAS REMOVED OVER THE WIRE. HOWEVER, THE TIP OF THE DILATOR [COAXIAL SHEATH] WAS NOTED TO BE MISSING. THEY DID ADVANCE A MICRO SNARE BUT THE TIP WAS NOT FOUND. THE POST PROCEDURE NOTE INDICATES MULTIPLE ATTEMPTS TO SNARE THE BROKEN OFF TIP, BUT THEY WERE UNSUCCESSFUL. MULTIPLE RIGHT LOWER EXTREMITY (RLE) RUNS WERE PERFORMED WITHOUT EVIDENCE OF THROMBOSIS. IT WAS NOTED ROBUST DISTAL RLE PULSES, AND RECOMMENDED CTA RUN OFF IF SYMPTOMS OF RLE ISCHEMIA OCCUR.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22943667 ↗MalfunctionSep 2, 2025Fracture; Fracture
AN END USER REPORTED AN ISSUE WITH A MINI STICK MAX 4F X 10 CM STD .018 SS/TU ECHO 2.75. DURING AN ANGIOGRAPHIC PROCEDURE, A MINISTICK MAX WAS USED FOR ACCESS TO RIGHT FEMORAL ARTERY. IT WAS REPORTED THAT MOST OF THE EXTERIOR CATHETER SPLIT INTO THE PATIENT. DOCTOR [NAME REDACTED] WAS CALLED TO PERFORM A CUT DOWN AND TO REMOVE THE FRAGMENT. THE PATIENT WAS INTUBATED AND SENT TO ICU.
Patient problems: Foreign Body In Patient
MAUDE report 22942746 ↗MalfunctionAug 4, 2025Fracture; Fracture
ANGIODYNAMICS WAS NOTIFIED OF AN EVENT FROM THE FDA, VOLUNTARY MEDWATCH MW5172360, REGARDING A MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU ECHO 2.75". IT WAS REPORTED THE DISTAL PORTION OF A MICROPUNCTURE SHEATH HAD BROKEN OFF AND REMAINED IN THE PATIENT'S GROIN DURING A LEFT HEART CATHETERIZATION.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 22701066 ↗MalfunctionMay 7, 2025Material Perforation; Material Perforation
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU ECHO 2.75". IT WAS REPORTED THAT DURING THE PROCEDURE, THE .035 GUIDEWIRE PUNCTURED THROUGH THE CATHETER AT THE HUB CAUSING EXTRAVATION AT THE PUNCTURE SITE. THIS MUDDIED THE IMAGING, MAKING RE-ACCESS MORE DIFFICULT. A REPEAT ACCESS INTO THE FEMORAL VEIN WAS REQUIRED DUE TO THIS EVENT. A NEW OF THE SAME DEVICE WAS USED FOR THE REPEAT ACCESS. THE PATIENT WAS REPORTED AS STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21977281 ↗MalfunctionMay 7, 2025Fracture; Fracture
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75". ON (B)(6) 2025 A PATIENT UNDERWENT LEFT GREATER SAPHENOUS VEIN VARITHENA PROCEDURE IN THE OFFICE WITH THE MINI STICK DEVICE. ON (B)(6) 2025 THE PATIENT WENT TO THE ER AND AN XRAY OF THEIR LEFT LEG REVEALED A PORTION OF THE RETAINED WIRE WITHIN THE SAPHENOUS VEIN. IT HAS YET TO BE REMOVED. THE DOCTOR BELIEVES IT WAS A DEFECTIVE WIRE OR NEEDLE WHICH RESULTED IN SEPARATION OF THE DISTAL PORTION OF THE WIRE DURING THE PROCEDURE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21977274 ↗
Other Navilyst Medical, Inc. products
All Navilyst Medical, Inc. devices →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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