AngioDynamics 45753Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI H965457530), received between Aug 31, 2016 and May 6, 2026 — classified as 8 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 reports).

15 other recalls cover devices cleared under the same FDA submission (K132713); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryFeb 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A CONFIDENTIAL REPORTER SUBMITTED A USER FACILITY MEDWATCH FOR A MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG. IT WAS REPORTED THAT A THIN PIECE OF WIRE WAS SHEARED OFF DURING INSERTION AND BECAME EMBEDDED IN THE SUBCUTANEOUS TISSUE, BENEATH THE SKIN, AT THE RIGHT INTERNAL JUGULAR.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18788082 ↗
• InjuryJan 24, 2023Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A MINI STICK MAX 4F X 10CM STIFF .018 SS/SS ECHO 2.75" PG. DURING A FEMORAL ARTERIOGRAM PROCEDURE, THE END BROKE OFF THE MICROPUNCTURE WIRE WHILE INSIDE THE PATIENT. THE PATIENT REQUIRED AN ADDITIONAL SURGERY TO REMOVE THE FRAGMENT, WHICH WAS REMOVED WITH NO ISSUES. THE INITIAL PROCEDURE WAS CANCELED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE FURTHER MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16232859 ↗
• MalfunctionJan 17, 2022Fracture; Fracture

  AN INTERVENTIONAL RADIOLOGY TECHNICIAN REPORTED AN ISSUE WITH A MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 2.75." DURING A PROCEDURE, WHEN THE DR. WENT TO REMOVE THE INNER DILATOR FROM THE SHEATH THE DILATOR BROKE OFF AT THE HUB. THE REMAINING DILATOR WAS IN THE SHEATH SO THE DR. USED A SNARE TO REMOVE IT FROM THE SHEATH. NO PART OF THE DILATOR BROKE OFF IN THE PATIENT AND THE PROCEDURE CONTINUED. 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 13266943 ↗
• MalfunctionJan 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A MINI STICK MAX 4F X 10CM. DURING A MICROPUNCTURE PROCEDURE, THE TIP OF THE GUIDEWIRE BROKE OFF IN THE PATIENT'S AV FISTULA. THE END USER WAS UNABLE TO RETRIEVE THE FRAGMENT; THEREFORE, THE PATIENT WAS SENT TO SURGERY A FEW DAYS LATER, FOR REMOVAL; HOWEVER, THE FRAGMENT WAS UNABLE TO BE REMOVED AND REMAINS INSIDE THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13257980 ↗
• MalfunctionNov 19, 2021Fracture; Fracture

  A CARDIOVASCULAR INVASIVE SPECIALIST REPORTED AN ISSUE WITH A MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO2.75" PG. DURING A PROCEDURE, THE SHAFT OF THE SHEATH BROKE OFF IN THE FEMORAL, WHILE THE PHYSICIAN WAS ATTEMPTING TO EXCHANGE. ANOTHER SHEATH WAS PULLED IN ORDER TO COMPLETE THE PROCEDURE. THE PHYSICIAN HAD TO SNARE THE REMAINING SHAFT OUT OF THE PATIENT. 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: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12842739 ↗
• InjuryMay 10, 2021Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  A RISK MANAGER REPORTED AN ISSUE WITH A MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG. DURING A PROCEDURE, WHILE A CLINICIAN WAS ATTEMPTING TO PLACE PERMACATH, THE MINI STICK MAX SHEATH SEPARATED FROM THE HUB, WHILE INSIDE OF THE PATIENT. THE MINI STICK SHEATH BECAME LODGED IN THE LEFT PULMONARY ARTERY. SEVERAL ATTEMPTS TO REMOVE THE MINI STICK SHEATH WERE UNSUCCESSFUL; THEREFORE, THE PATIENT WAS MOVED TO CT TO CONFIRM PLACEMENT AND AN INTERVENTIONAL RADIOLOGIST (IR) WAS CALLED IN TO ATTEMPT RETRIEVAL. THE PLACEMENT OF THE PERMACATH WAS COMPLETED, BUT REQUIRED REPLACEMENT DUE TO THE SEPARATION OF THE MINI STICK SHEATH FRAGMENT, WHICH HAD BECOME DISLODGED AND EMBOLIZED IN THE LEFT PULMONARY ARTERY. THE IR WAS ABLE TO SUCCESSFULLY REMOVE THE MINI STICK SHEATH; TREATMENT WAS COMPLETED ON THE SAME DAY BY THE ON-CALL SPECIALIST WHO WAS SUCCESSFUL IN RETRIEVING THE MINI STICK SHEATH FRAGMENT WITH A SNARE AND THE REPLACEMENT OF THE PERMACATH WITHOUT FURTHER COMPLICATIONS. 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 11797998 ↗
• MalfunctionFeb 17, 2021Fracture

  A RISK MANAGER SUBMITTED A SUS VOLUNTARY EVENT REPORT REGARDING AN ISSUE WITH A MINI STICK MAX. DURING A PROCEDURE, WHEN THE DILATOR FROM THE MINI STICK WAS REMOVED, ONLY HALF OF THE DILATOR CATH WAS ON THE WIRE. A SNARE WAS USED TO REMOVE TWO LARGE PIECES AND A STENT WAS USED TO SECURE THE REMAINING PIECE AGAINST THE PATIENT'S ARTERIAL WALL. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11337289 ↗
• InjuryDec 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ANGIODYNAMICS TERRITORY MANAGER (TM) REPORTED AN ISSUE WITH A MINI STICK MAX. DURING A PROCEDURE, THE TIP OF THE MSM SHEATH WAS SLICED OFF BY THE BALLOON, INSIDE OF THE VESSEL. THIS OCCURRED AT THE TAIL END OF A SUCCESSFUL ATHERECTOMY PROCEDURE. THE PHYSICIAN TRANSFERRED THE PATIENT TO THE HOSPITAL SO A SURGICAL CUT-DOWN COULD BE PERFORMED TO REMOVE THE REMAINING PIECE. THE PIECE WAS ABLE TO BE REMOVED AND THE PATIENT DID NOT EXPERIENCE ANY HARM DUE TO THE 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: Device Embedded In Tissue or Plaque

  MAUDE report 10927089 ↗
• InjuryAug 26, 2019Fracture; Fracture

  AS REPORTED: MINISTICK MAX USED TO ACCESS THE FEMORAL ARTERY, AT SOME POINT THE SHAFT SEPARATED FROM THE BODY AND WAS RETAINED INSIDE THE ARTERY. THE SURGEON HAD TO CUT DOWN FEMORAL ARTERY TO REMOVE THE BROKEN PIECE. PATIENT SUSTAINED NO INJURIES. THEY WERE ABLE TO PROCEED WITH THE PROCEDURE WITH NO MAJOR ADVERSE INJURY TO PATIENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8932201 ↗
• InjuryAug 14, 2017Fracture; Fracture

  AS REPORTED ON VOLUNTARY MEDWATCH MW5070787, " MINISTICK WAS USED TO GAIN ACCESS TO THE RIGHT FEMORAL ARTERY. THE PHYSICIAN PLACED THE MINISTICK WIRE AND THE DILATOR/SHEATH THAT COMES WITH THE KIT AND REMOVED THE INNER SHEATH AND WIRE TO REPLACE WITH 4F SHEATH/WIRE THEN THE MINISTICK WIRE BROKE OFF INTO THE PATIENT. DR. ASKED FOR CONSULT. IT WAS DECIDED TO REMOVE THE MINISTICK SHEATH AND PERFORM A CUT-DOWN IN WHICH THEY USED A SCALPEL AND HEMOSTAT TO RETRIEVE THE WIRE. PRESSURE WAS HELD TO RIGHT GROIN, FLUORO WAS UTILIZED TO DETERMINE ALL OF THE WIRE WAS RETRIEVED AND THEN PROCEDURE WAS CONTINUED WITH GAINING ACCESS TO THE LEFT GROIN WITHOUT MINISTICK. POST-PROCEDURE RIGHT GROIN WAS SOFT TO TOUCH. NO HEMATOMAS AND TEGADERM WAS PLACED OVER THE SITE AND PATIENT DENIED ANY TENDERNESS." IT HAS BEEN INDICATED THAT THE GUIDEWIRE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6792657 ↗
• InjurySep 1, 2016Crack; Migration or Expulsion of Device; Crack; Migration or Expulsion of Device

  DURING ACCESS TO THE POPLITEAL VEIN, THE GUIDEWIRE IN THE MICRO-ACCESS KIT SHEARED APART. THE PHYSICIAN WAS SUCCESSFULLY ABLE TO RETRIEVE A SMALL PIECE OF WIRE FROM THE PATIENT'S LEG. THE DEVICE FROM THE REPORTED EVENT IS BEING RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED TO ANGIODYNAMICS.

  Patient problems: Foreign Body In Patient

  MAUDE report 5922530 ↗
• InjuryAug 31, 2016Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device

  AS REPORTED, AN ANGIODYNAMICS MICROPUNCTURE KIT SHEATH WAS BEING USED TO ACCESS A DIALYSIS GRAFT. AFTER .035 WIRE EXCHANGE AND DURING SHEATH REMOVAL THE MICROPUNCTURE SHEATH STRETCHED AND EVENTUALLY SHEARED OFF IN THE GRAFT. THIS RESULTED IN THE NECESSITY OF RETRIEVING THE REMAINING SHEATH INTRAVASCULARLY WITH A SNARE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5917388 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132713. One submission often covers many models, so check the product and lot details in each record.

• Z-1336-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751
• Z-1343-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
• Z-1339-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
• Z-1348-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
• Z-1346-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775
• Z-1337-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-752
• Z-1347-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-776
• Z-1338-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754
• Z-1334-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749
• Z-1341-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759
• Z-1345-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774
• Z-1340-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-758
• Z-1342-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-762
• Z-1344-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767
• Z-1335-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750