AccuVuRecalls & reported problems across all models
Angiodynamics, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one AccuVu model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 4
We found 9 models of AccuVu by Angiodynamics, Inc. in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between Apr 28, 2016 and Mar 21, 2022 — classified as 4 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Fracture” (7 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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
AccuVu 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-1875-2026 · 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-1874-2026 · 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-1873-2026 · 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-1872-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported AccuVu problems
Device problems
- Fracture7
- Crack3
- Detachment of Device or Device Component3
- Adverse Event Without Identified Device or Use Problem1
- Detachment Of Device Component1
- Device Issue1
- Insufficient Device Problem Information1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Device Embedded In Tissue or Plaque6
- No Known Impact Or Consequence To Patient5
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
AccuVu models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AccuVu 13709804CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall2 reports
- AccuVu 13709005CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- AccuVu 13709604CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- AccuVu 13709704CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- AccuVu 13709703CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- AccuVu 13709801CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- AccuVu 13709701CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- AccuVu 13709803CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- AccuVu 13709802CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
Recent AccuVu adverse event reports
The 14 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
AN END USER REPORTED AN ISSUE WITH AN AV 5 100 035 OF 1CM 21RO SIZING CATHETER. DURING THE PROCEDURE, THE MARKER FELL OFF, INTO THE PATIENT. THE DECISION WAS MADE TO LEAVE THE MARKER IN SITU. THE PROCEDURE WAS COMPLETED WITH THIS CATHETER. THE TREATING PHYSICIAN ATTRIBUTED THE MARKERBAND DETACHMENT POSSIBLY TO ITS USE WITH THE COOK RUPS SET. DURING THE PROCEDURE, THE CATHETER IS WITHDRAWN THROUGH THE METAL CANNULA SEVERAL TIMES DURING A CASE AND IN DOING SO, IT MAY HAVE CAUSED THE MARKERBAND TO DETACH. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 13840066 ↗MalfunctionNov 3, 2020Fracture; Fracture
AN END USER REPORTED AN ISSUE WITH AN AV 5 70 038 PT 1CM 21RO SIZING ANGIOGRAPHIC CATHETER. DURING A PROCEDURE, THE CATHETER TIP SEPARATED INSIDE OF THE PATIENT DURING AN AAA STENT GRAFT PLACEMENT. THE DEVICE WAS ABLE TO BE REMOVED FROM THE PATIENT, USING A SNARE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10777218 ↗MalfunctionOct 24, 2020Fracture; Fracture
A DISTRIBUTOR REPORTED AN ISSUE WITH AN ANGIOGRAPHIC CATHETER WHILE PREPARING FOR A PROCEDURE. DURING ASSEMBLY WITH THE GUIDEWIRE, THE CATHETER TIP BROKE INTO SEVERAL PIECES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10731846 ↗InjuryJul 8, 2020Fracture; Fracture
ANGIODYNAMICS RECEIVED FDA MEDWATCH REFERENCE MW5094777. A RISK MANAGER REPORTED THAT THE ACCU-VU OMNI FLUSH CATHETER BROKEN IN HALF WHEN THE POWER INJECTOR WAS TRIGGERED. THE PRACTITIONER WAS ABLE TO SAFELY RETRIEVE THE CATHETER FROM THE FEMORAL ARTERY. NO END USER IDENTIFYING INFORMATION WAS PROVIDED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10247242 ↗InjuryFeb 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ANGIODYNAMICS RECEIVED A ANGIOGRAPHIC CATHETER DEVICE THAT THE TIP HAD DETACHED FROM THE CATHETER SHAFT. THE DEVICE FAILURE WAS NOT REPORTED PREVIOUSLY AND HAD BEEN RETURNED WITH ANOTHER SAMPLE FOR A DIFFERENT COMPLAINT RECORD FROM THE SAME ACCOUNT FOR THE SAME FAILURE. .
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9699595 ↗InjuryJan 21, 2020Fracture; Fracture
AS REPORTED: AN ACCUVU ANGIOGRAPHIC CATHETER WAS USED IN ENDOVASCULAR CASE. THE CATHETER WAS INSERTED AND REMOVED FROM PATIENT WITHOUT INCIDENT MULTIPLE TIMES. ON ONE ATTEMPT TO RE-INSERT; THE RADIOPAQUE TIP WAS FOUND TO BE BROKEN/DETACHED INTO MULTIPLE PIECES (CATHETER AND THREE FRAGMENTS; TWO IN BIOHAZARD BAG FOR RETURN TO MANUFACTURER AND ONE REMAINING IN PATIENT'S BODY). ONE OF THE FRAGMENTS REMAINS INSIDE PATIENT; NO KNOWN INJURY AT THIS TIME. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9611619 ↗MalfunctionSep 25, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: WHEN PREPPING FOR AN ANGIOGRAPHIC PROCEDURE, IT WAS NOTED THE STERILE PACKAGING OF THE ACCU-VU CATHETER WAS TORN, COMPROMISING THE STERILITY OF THE DEVICE. THE PACKAGE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7907020 ↗MalfunctionNov 29, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: DURING PREP FOR AN ANGIOGRAPHIC PROCEDURE, IT WAS REPORTED THE TIP OF THE ANGIOGRAPHIC CATHETER DETACHED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7068046 ↗InjurySep 20, 2017Crack; Crack
AS REPORTED TO ANGIODYNAMICS ON SEPTEMBER 01, 2017: DURING A TIPSS PROCEDURE, THE CATHETER TIP BROKE OFF INSIDE OF THE PATIENT. THE FRAGMENT WAS SUCCESSFULLY REMOVED VIA A SNARE. THE DEVICE WAS REMOVED AND SET ASIDE. THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT SUFFER ANY HARM OR INJURY DUE TO THIS EVENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6878973 ↗MalfunctionSep 20, 2017Fracture; Fracture
AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017 VIA A (B)(4); THE OMNI FLUSH CATHETER WAS PLACED OVER A GLIDE WIRE. THE GLIDE WIRE WAS REMOVED FOR INJECTION OF CONTRAST VIA POWER INJECTOR FOR VISUALIZATION. THE INJECTION WAS NOT COMPLETE AFTER THREE ATTEMPTS. THE OMNI FLUSH CATHETER FOUND WITH A TEAR/ LARGE HOLE IN CATHETER, THUS MAKING IT UNABLE TO DELIVER THE CONTRACT TO THE END OF THE CATHETER. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6878968 ↗MalfunctionApr 6, 2017Crack; Fracture; Crack; Fracture
AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: THE 4FR PIGTAIL ACCUVU CATHETER FAILED YESTERDAY (B)(6) 2017 EVENING. THE BLACK RADIOPAQUE DISTAL TIPS DETACHED FROM THE CATHETER WHILE IT WAS ON THE BACK TABLE. THE PHYSICIAN FELT RESISTANCE WHEN HE WAS ADVANCING THE CATHETER OVER THE WIRE. THE CATHETER ENTERED THE PATIENT BUT WAS STILL IN THE SHEATH. THEY REMOVED THE CATHETER AND THE TIP HAD SHEARED OFF. THE PATIENT WAS NOT AFFECTED BY THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient
MAUDE report 6464824 ↗MalfunctionApr 6, 2017Crack; Fracture; Crack; Fracture
AS REPORTED TO ANGIODYNAMICS ON MARCH 14, 2017: THE 4FR PIGTAIL ACCUVU CATHETER FAILED YESTERDAY ((B)(6) 2017) EVENING. THE BLACK RADIOPAQUE DISTAL TIPS DETACHED FROM THE CATHETER WHILE IT WAS ON THE BACK TABLE. THE PHYSICIAN FELT RESISTANCE WHEN HE WAS ADVANCING THE CATHETER OVER THE WIRE. THE CATHETER ENTERED THE PATIENT BUT WAS STILL IN THE SHEATH. THEY REMOVED THE CATHETER AND THE TIP HAD SHEARED OFF. THE PATIENT WAS NOT AFFECTED BY THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6464816 ↗MalfunctionMay 18, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue
AS REPORTED (B)(6) 2016, A (B)(6), MALE PATIENT PRESENTED FOR AN ANGIOGRAPHIC PROCEDURE. DURING THE CASE, AFTER THE ANGIOGRAPHIC CATHETER HAD BEEN PLACED, THE STRAIN RELIEF DETACHED AND SLID DOWN THE CATHETER SHAFT AND INTO THE INSERTION SITE. THE STRAIN RELIEF WAS REMOVED WITH NO COMPLICATIONS OR PATIENT EFFECT. THE CATHETER WAS REMOVED AND SET ASIDE. A NEW OF THE SAME WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 5662540 ↗MalfunctionApr 28, 2016Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
AS REPORTED APRIL 05, 2016, A (B)(6), FEMALE PATIENT PRESENTED FOR AN ANGIOGRAPHIC PROCEDURE FOR A FILTER REMOVAL. DURING THE CASE, UPON THREADING THE CATHETER OVER THE WIRE, THE PHYSICIAN NOTED THE CATHETER TO BE SPLIT. THE CATHETER WAS REMOVED FROM THE WIRE WITH NO REPORTED COMPLICATIONS. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5615760 ↗
Other Angiodynamics, Inc. products
- Soft-Vu54 models · 66 reports · 18 recalls
- Mini Stick MAX12 models · 2 reports · 12 recalls
- Smart Port CT36 models · 479 reports
- VenaCure EVLT15 models · 437 reports
- 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.
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