Mini Stick MAXRecalls & reported problems across all models
Angiodynamics, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
12 open recalls name at least one Mini Stick MAX model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 12
We found 12 models of Mini Stick MAX by Angiodynamics, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Aug 7, 2025 and Jul 9, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).
12 FDA recall records name at least one of these models by its device identifier, 12 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
Mini Stick MAX 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.
- Jan 30, 2024Open, Classified
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Z-1348-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jan 30, 2024Open, Classified
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Z-1347-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jan 30, 2024Open, Classified
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Z-1346-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jan 30, 2024Open, Classified
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Z-1345-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jan 30, 2024Open, Classified
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Z-1341-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jan 30, 2024Open, Classified
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Z-1340-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jan 30, 2024Open, Classified
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Z-1339-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jan 30, 2024Open, Classified
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Z-1338-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jan 30, 2024Open, Classified
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Z-1337-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jan 30, 2024Open, Classified
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Z-1336-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jan 30, 2024Open, Classified
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Z-1335-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jan 30, 2024Open, Classified
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Z-1334-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported Mini Stick MAX problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- Foreign Body In Patient2
Mini Stick MAX models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Mini Stick MAX H965457490DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
- Mini Stick MAX H965457510DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
- Mini Stick MAX H965457500DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall0 reports
- Mini Stick MAX H965457520DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall0 reports
- Mini Stick MAX H965457540DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall0 reports
- Mini Stick MAX H965457560DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall0 reports
- Mini Stick MAX H965457580DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall0 reports
- Mini Stick MAX H965457590DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall0 reports
- Mini Stick MAX H965457740DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall0 reports
- Mini Stick MAX H965457750DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall0 reports
- Mini Stick MAX H965457760DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall0 reports
- Mini Stick MAX H965457810DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall0 reports
Recent Mini Stick MAX adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2026
ON [REDACTED], THE PHYSICIAN WAS PERFORMING RIGHT INTERNAL JUGULAR VENOUS ACCESS FOR A RIGHT HEART CATHETERIZATION UNDER ULTRASOUND GUIDANCE. ACCORDING TO THE MEDICAL RECORD, ON THE SECOND ATTEMPT TO ACCESS, THE WIRE ENTERED A DISSECTION PLANE JUST PAST THE NEEDLE TIP AND WAS UNABLE TO BE REMOVED FROM THE SOFT TISSUE. THE WIRE DID NOT APPEAR TO BE IN THE VESSEL BASED ON FLUOROSCOPY. THE PHYSICIAN ATTEMPTED TO MANEUVER THE WIRE OUT OF THE SOFT TISSUE WITHOUT SUCCESS. THE WIRE TIP BROKE DURING MANIPULATION AND WAS RETAINED IN THE SOFT TISSUE. THE RETAINED FOREIGN OBJECT REMAINED IN PLACE UNTIL [REDACTED]-4 DAYS LATER- WHEN IT WAS SUCCESSFULLY REMOVED FROM THE TISSUE SURROUNDING THE RIGHT INTERNAL JUGULAR VEIN.
Patient problems: Foreign Body In Patient
MAUDE report 25763010 ↗InjuryAug 7, 2025Material Split, Cut or Torn
USED MINISTICK MAX FOR ACCESS TO RIGHT FEMORAL ARTERY. MOST OF EXTERIOR CATHETER SPLIT INTO PATIENT. HAD TO CALL DR [(B)(6)] TO CUT DOWN AND REMOVE DEVICE. PATIENT INTUBATED AND SENT TO ICU.
Patient problems: Foreign Body In Patient
MAUDE report 22737194 ↗
Other Angiodynamics, Inc. products
- Soft-Vu54 models · 66 reports · 18 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.
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