Soft-VuRecalls & reported problems across all models
Angiodynamics, Inc. · 54 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
18 open recalls name at least one Soft-Vu model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 66
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls
- 18
We found 54 models of Soft-Vu by Angiodynamics, Inc. in the FDA's device registry (GUDID). Together they are named in 66 adverse event reports in the FDA's MAUDE database, received between Jun 30, 2016 and Dec 17, 2025 — classified as 29 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (30 reports).
18 FDA recall records name at least one of these models by its device identifier, 18 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
Soft-Vu 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.
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1871-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1870-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1869-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1868-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1867-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1866-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1865-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1864-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1863-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1862-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1861-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1860-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1859-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1858-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1857-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Mar 3, 2026Open, Classified
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Z-1856-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Jun 18, 2024Open, Classified
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
Z-2454-2024 · Root cause: Packaging change control · Recall details · FDA record ↗
- Jun 18, 2024Open, Classified
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
Z-2453-2024 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported Soft-Vu problems
Device problems
- Detachment of Device or Device Component30
- Crack14
- Fracture13
- Break3
- Device Damaged Prior to Use3
- Difficult to Advance3
- Entrapment of Device3
- Detachment Of Device Component2
Patient problems
- Device Embedded In Tissue or Plaque27
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient11
- No Known Impact Or Consequence To Patient8
- Foreign Body In Patient5
- Aortic Dissection3
- Infiltration into Tissue3
- No Patient Involvement3
Soft-Vu models
54 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Soft-Vu 10732301CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall6 reports
- Soft-Vu 10732701CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall2 reports
- Soft-Vu 10714009CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- Soft-Vu 10734301CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- Soft-Vu 10707103CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10710013CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714001CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714002CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714011CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714014CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714016CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714017CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714018CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714021CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714024CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714040CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10731401CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10732702CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10723502CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- Soft-Vu 10732205CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- Soft-Vu 10733201CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- Soft-Vu 10709402CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Soft-Vu 10712006CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Soft-Vu 10719503CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Soft-Vu 10708903CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Soft-Vu 10709101CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Soft-Vu 10722708CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Soft-Vu 10732201CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Soft-Vu 10732203CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Soft-Vu 10707101CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10708905CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10709108CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10709301CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10712001CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10712004CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10712005CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10712008CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10714004CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10714033CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10719606CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10719608CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10719708CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10719709CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10720202CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10722102CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10722105CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10723503CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10732202CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10732302CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10733401CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10734101CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 10735401CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 50702301CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Soft-Vu 50722631CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
Recent Soft-Vu adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
AN END USER REPORTED AN ISSUE WITH A SOFT-VU BER 5F X 100CM 038 NB 0SH. DURING THE PROCEDURE, THE CATHETER FRACTURED OFF INSIDE THE PATIENT AS THEY WERE TAKING IT OFF THE WIRE. IT WAS REPORTED ALL FRAGMENTS WERE RETRIEVED.
Patient problems: Foreign Body In Patient
MAUDE report 23826622 ↗MalfunctionOct 23, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A SOFT-VU RIM 4F X 65CM 035 B 0SH. DURING A PTA CROSSOVER FROM RIGHT TO LEFT PROCEDURE, THE TIP OF THE CATHETER DETACHED INSIDE OF THE PATIENT. A COOK 180CM AMPLATZ WIRE WAS BEING USED AT THE TIME. THE TIP WAS REMOVED USING ANOTHER INSTRUMENT. THE PROCEDURE WAS THEN COMPLETED WITH A NEW OF THE SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23367678 ↗MalfunctionJul 9, 2025Fracture; Fracture
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A SOFT-VU OF 4F X 65CM 035 NB 6SH. THEY PUT THE OMNI FLUSH CATHETER OVER A .035 BENTSON WIRE WITH NO ISSUES INTO THE ABDOMINAL AORTA AND POWER INJECTED AN AORTOGRAM. THEY THEN USED A .035 STANDARD ANGLED GLIDE WIRE TO GO OVER THE AORTIC BIFURCATION INTO THE SFA. THERE WAS A NORMAL AORTIC BIFURCATION, NO STENTS, STENOSIS OR IRREGULARITY SEEN IN THE ILIAC SYSTEMS. A LOWER EXTREMITY RUNOFF WAS PERFORMED THROUGH THE OMNI FLUSH AND IDENTIFIED SFA AND POP DISEASE. AT THIS POINT A .035 ABBOTT SUPRACORE WAS PASSED THROUGH THE CATHETER INTO THE SFA AND THE CATHETER WAS PULLED BACK, WHEN THE TIP OF THE CATHETER REACHED THE AORTIC BIFURCATION THERE WAS SOME RESISTANCE. THEY PUSHED THE CATHETER SLIGHTLY FORWARD AGAIN AND IT WENT EASILY, BEGAN TO WITHDRAW AGAIN AND THE TIP OF THE CATHETER SEPARATED ON THE WIRE FROM THE REST OF THE CATHETER. THEY PULLED THE CATHETER OFF AND PLACED A 6FR 45CM TERUMO DESTINATION OVER THE WIRE AND TELESCOPED THE SHEATH OFF THE DILATOR WHEN THEY REACHED THE BROKEN TIP AND THE TIP WENT INTO THE SHEATH STILL OVER THE WIRE. THEY DISCONNECTED THE SHEATH HUB AND SLOWLY PULLED THE WIRE BACK UNTIL THE
Patient problems: Infiltration into Tissue; No Clinical Signs, Symptoms or Conditions
MAUDE report 22461858 ↗MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A CARDIOLOGIST REPORTED AN ISSUE WITH A SOFT-VU OF 4F X 90CM 038 NB 6SH. DURING A PROCEDURE, THE CATHETER WAS ADVANCED AND HIT CALCIFICATION, RESULTING IN THE TIP OF CATHETER BREAKING OFF, INTO THE PATIENT. THE TIP WAS RECOVERED IMMEDIATELY AND PATIENT DID NOT REQUIRE FURTHER INTERVENTION. ULTIMATELY, THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 21228615 ↗MalfunctionNov 13, 2024Fracture; Fracture
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A SOFT-VU KMP 5F X 65CM 038 NB 0SH.CUSTOMER WAS RETRACTING OUT OF VESSEL AND NOT ALL OF THE CATHETER WAS THERE. THE PATIENT WAS SENT TO THE HOSPITAL FOR FURTHER EVALUATION. ADDITIONAL INFORMATION: TYPE OF PROCEDURE: THROMBECTOMY. NO OTHER TOOLS- CATHETER WAS OVER A GUIDE WIRE. NO TORTUOUS ANATOMY. THERE WAS A STENT IN THE OUTFLOW TRACT. NO RESISTANCE WHEN PASSING ANYTHING IN HOWEVER IT TORE WHEN PULLED BACK.
Patient problems: Infiltration into Tissue
MAUDE report 20673339 ↗MalfunctionOct 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AN END USER REPORTED AN ISSUE WITH A SOFT-VU OF 5F X 65CM 035 NB 6SH. THE RADIO-OPAQUE DISTAL TIP OF THE CATHETER DETACHED FROM THE REST OF THE CATHETER DURING MID PROCEDURE.
Patient problems: Infiltration into Tissue
MAUDE report 20407413 ↗InjurySep 13, 2023Fracture; Migration; Fracture; Migration
AN END USER REPORTED AN ISSUE WITH A SOFT-VU 90PT 6F X 100CM 038 B 10SH CATHETER. THE CATHETER INTRODUCER CHEATER ON THE END OF THE CATHETER [TIP STRAIGHTENER SLEEVE TUBING], THAT IS USED TO STRAIGHTEN THE TIP OF THE CATHETER, WAS INTRODUCED INTO THE PATIENT DURING A PULMONARY EMBOLISM CASE. THIS PIECE WENT UNNOTICED DURING THE PE CASE. THE PATIENT RETURNED TO THEIR ROOM AND WAS HAVING COMPLICATIONS. THE NEXT DAY THE PATIENT WENT FOR A CT OF THE CHEST WHERE A FOREIGN BODY WAS FOUND IN THE PULMONARY ARTERY. THE PATIENT THEN UNDERWENT A FOREIGN BODY RETRIEVAL AND THE PIECE WAS REMOVED FROM THE PATIENT. A COMPLETE ROOT CAUSE ANALYSIS WAS COMPLETED AND WE ARE ASKING THAT ANGIODYNAMICS MAKES THIS PLASTIC PIECE A DIFFERENT COLOR OTHER THAN WHITE. PERHAPS HAVING THIS PIECE A BRIGHT COLOR WILL HELP PREVENT THE OBJECT FROM BEING ENTERED INTO A SHEATH AND ULTIMATELY THE PATIENTS BODY.
Patient problems: Foreign Body In Patient
MAUDE report 17736650 ↗MalfunctionApr 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
DURING THE PROCEDURE, AFTER THE SOFT-VU KMP 4F X 40CM 035 NB 0SH CATHETER HAD BEEN THREADED OVER THE WIRE, THE TIP OF THE CATHETER DETACHED INSIDE THE PATIENT. THIS WAS NOTICED WHEN WITHDRAWING THE WIRE FROM THE PATIENT. THE TIP REMAINED ON THE WIRE, AND WAS NOT RETAINED INSIDE THE PATIENT. THE CATHETER WAS REPLACED WITH A NEW OF THE SAME DEVICE AND THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16662508 ↗MalfunctionMar 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AN END USER EXPERIENCED AN ISSUE WHEN USING THE ANGIOGRAPHIC CATHETER FROM A SOFT-VU OF 5F X 65CM 038 NB 6SH KIT. DURING THE PROCEDURE, THE TIP OF THE CATHETER DETACHED INSIDE THE PATIENT IN THE POPLITEAL VEIN. THE TIP WAS ABLE TO BE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. IT WAS REPORTED THE PATIENT WAS STABLE DUE TO THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 16645618 ↗MalfunctionAug 9, 2022Difficult to Remove; Material Deformation; Material Twisted/Bent
MID 90¿S MALE WITH HISTORY OF RECENT ACUTE BLOOD LOSS ANEMIA AND GI BLEED. PROCEDURE: ARTERIOGRAM THROUGH RIGHT GROIN. THE ANGIODYNAMICS TWISTED AND KINKED, INSIDE THE PATIENT'S VESSEL. IT WAS VERY DIFFICULT TO REMOVE FROM THE SHEATH. DEVICE WAS REMOVED INTACT, WITHOUT KNOWN HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15190438 ↗MalfunctionJun 7, 2022Fracture; Fracture
AN END USER REPORTED AN ISSUE WITH A SV SW1 5FX100CM .038 NB. ANGIOGRAPHIC CATHETER. DURING A PROCEDURE, THE CATHETER KINKED NEAR THE END AND CRACKED. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14621504 ↗MalfunctionApr 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED AN ISSUE WITH A SV BEREN 4FX65CM .035 B ANGIOGRAPHIC CATHETER. DURING AN ANGIOGRAM PROCEDURE, THE CATHETER TIP BROKE OFF WHILE THE DEVICE WAS BEING WITHDRAWN FROM THE PATIENT. THE TIP FRAGMENT WAS REMOVED VIA SNARE AND THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS ISSUE.
Patient problems: Foreign Body In Patient
MAUDE report 13977453 ↗MalfunctionJun 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
AN END USER REPORTED AN ISSUE WITH A SV BER 4FX65CM .038 NB ANGIOGRAPHIC CATHETER. DURING A PROCEDURE TO PLACE A BILIARY DRAIN,THE DOCTOR REPORTED USING THE CATHETER THROUGH AN ACCUSTICK AND OVER A 0.035 AMPALTZ WIRE. HE REPORTED HE HAD TO PUSH PRETTY HARD TO GET THE CATHETER THROUGH THE TUMOR TO THE BOWEL. ON WITHDRAWAL, THE END GOT STUCK IN THE END OF THE ACCUSTICK, AND WHEN FORCE WAS APPLIED TO REMOVE IT, THE TIP BROKE OFF. HE PULLED EVERYTHING BACK AS A UNIT AND THE TIP CAME OUT WITH THE ACCUSTICK. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11965762 ↗MalfunctionFeb 17, 2021Detachment of Device or Device Component
AN END USER REPORTED AN ISSUE, VIA AN END USER MEDWATCH, WITH AN ANGIOGRAPHIC CATHETER. IT WAS REPORTED THAT THE RADIOGRAPHIC TIP OF THE CATHETER SEPARATED FROM THE SHAFT, WHILE ON A 0.35 GLIDE ADVANTAGE WIRE. THIS OCCURRED PRIOR TO ENTERING THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11339847 ↗MalfunctionFeb 17, 2021Detachment of Device or Device Component
AN END USER REPORTED AN ISSUE WITH A SOFT-VU RIM ANGIOGRAPHIC CATHETER. THEY WERE REMOVING THE 4F RIM OVER A TERUMO GLIDE WIRE AND THE TIP RIPPED OFF (DETACHED) WHILE OUTSIDE THE PATIENT. THERE WAS NO HARM TO THE PATIENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11339545 ↗
Other Angiodynamics, Inc. products
- Mini Stick MAX12 models · 2 reports · 12 recalls
- Smart Port CT36 models · 479 reports
- VenaCure EVLT15 models · 437 reports
- AccuVu9 models · 14 reports · 4 recalls
- DuraMax8 models · 23 reports · 3 recalls
- Solero4 models · 154 reports
- DuraFlow6 models · 8 reports · 2 recalls
- NanoKnife9 models · 44 reports · 1 recall
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