AngioDynamics 45750Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI H965457500), received between Sep 26, 2017 and May 6, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED THAT THE DILATOR, FROM A MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG BROKE OFF, INSIDE OF THE PATIENT. THE FRAGMENT WAS ABLE TO BE REMOVED, VIA SNARE AND THE REMAINING PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19036693 ↗
• MalfunctionJan 15, 2024Device Damaged by Another Device; Device Damaged by Another Device

  DR (B)(6) REPORTED AN ISSUE WITH A MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG THAT OCCURRED DURING A PACEMAKER PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE PROXIMAL END OF THE GUIDEWIRE WAS DISSECTED WITH A BOVIE, DURING ACCESS. AFTER ACCESSING THE NITINOL GUIDEWIRE, THE PHYSICIAN STARTED TO DISSECT WITH THE BOVIE, WHEN HE CAME INTO CONTACT WITH THE GUIDEWIRE AND SLICED IT. THIS HAD NEVER OCCURRED PRIOR, AND HE WAS QUESTIONING THE MATERIAL OF THE GUIDEWIRE AND WHY IT OCCURRED. THERE WAS NO IMPACT OR HARM TO THE PATIENT AND THE PROCEDURE WAS ABLE TO BE COMPLETED BY PULLING THE GUIDEWIRE BACK..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510978 ↗
• MalfunctionJan 15, 2024Device Damaged by Another Device; Device Damaged by Another Device

  DR (B)(6) REPORTED AN ISSUE WITH A MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG THAT OCCURRED DURING A PACEMAKER PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE PROXIMAL END OF THE GUIDEWIRE WAS DISSECTED WITH A BOVIE, DURING ACCESS. AFTER ACCESSING THE NITINOL GUIDEWIRE, THE PHYSICIAN STARTED TO DISSECT WITH THE BOVIE, WHEN HE CAME INTO CONTACT WITH THE GUIDEWIRE AND SLICED IT. THIS HAD NEVER OCCURRED PRIOR, AND HE WAS QUESTIONING THE MATERIAL OF THE GUIDEWIRE AND WHY IT OCCURRED. THERE WAS NO IMPACT OR HARM TO THE PATIENT AND THE PROCEDURE WAS ABLE TO BE COMPLETED BY PULLING THE GUIDEWIRE BACK..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510977 ↗
• MalfunctionDec 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A RISK MANAGER REPORTED AN ISSUE WITH A MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG. THE FOLLOWING WAS REPORTED VIA A USER FACILITY MEDWATCH MW5148289 AND MW5148290: IR INSERT TUNNELED CENTRAL VENOUS CATHETER WO PORT OR PUMP MORE 5YRS RIGHT PLANNED PROCEDURE ON (B)(6) 2023: ULTRASOUND-GUIDED PERCUTANEOUS ACCESS OF RIGHT JUGULAR VEIN AND ATTEMPTED FLUOROSCOPICALLY GUIDED RETRIEVAL OF RETAINED FOREIGN BODY ON (B)(6) 2023. CLINICAL HISTORY/PREPROCEDURE DIAGNOSIS: 34-YEAR-OLD FEMALE WITH END STAGE RENAL DISEASE ON HEMODIALYSIS. SHE WAS ADMITTED FOR CONCERN OF MALFUNCTIONING LEFT ARTERIOVENOUS FISTULA. LEFT AV FISTULA REQUIRES SURGICAL INTERVENTION AND DECISION MADE FOR PERMCATH PLACEMENT UNTIL THAT DATE. POST-PROCEDURE DIAGNOSIS: SAME ACCESS SITE: RIGHT INTERNAL JUGULAR VEIN PROCEDURE: AFTER DISCUSSION OF THE RISKS, BENEFITS AND ALTERNATIVES, AS WELL AS ANSWERING THE PATIENT'S QUESTIONS, INFORMED CONSENT WAS OBTAINED. DURING THE CONSENT PROCESS, SOLE MEDICAL USE OF THE CENTRAL VENOUS ACCESS CATHETER WAS DISCUSSED, AND THE PATIENT WAS INSTRUCTED AND AGREED NOT TO USE THE DEVICE FOR ANY OTHER PURPOSE. THE PATIENT'S HISTORY OF CENTRAL VENOUS ACCESS WAS REVIEWED AND NON DEDICATE

  Patient problems: Foreign Body In Patient

  MAUDE report 18409651 ↗
• MalfunctionMay 15, 2023Fracture; Fracture

  DURING A PROCEDURE, USING A SHEATH FROM A MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" KIT, IT WAS REPORTED THAT 8CM OF THE SHEATH BROKE OFF INTO PATIENT. THE FRAGMENT WAS LOCATED IN THE RIGHT ARM (FISTULA). THE FRAGMENT WAS REMOVED VIA 7FR SNARE. THE SHEATH POTENTIALLY BROKE OFF DUE TO BEING BENT AND BREAKING IN HALF. THE PROCEDURE WAS COMPLETED THE FOLLOWING DAY WITH ANOTHER KIT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE IMPACT DUE TO THIS ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16932472 ↗
• MalfunctionSep 13, 2022Fracture; Fracture

  IT WAS REPORTED BY THE PROVIDER THAT THE PATIENT'S RIGHT IJV VEIN WAS ACCESSED EASILY WITH THE NEEDLE WITH EXCELLENT BLOOD RETURN.THE MICRO-WIRE WAS ADVANCED ASSURING BEVEL IN THE "UP" POSITION. THE WIRE WAS THEN FOUND TO BE COILED IN THE VEIN SO WAS WITHDRAWN. ON WITHDRAWAL, THE WIRE "JAMMED" IN THE NEEDLE. THE NEEDLE WAS THEN BACKED OUT SLOWLY AS THE WIRE WOULD NOT MOVE AND THE WIRE WAS DISSECTED FREE FROM ANY SURROUNDING TISSUE DIRECTLY AT THE PUNCTURE. DESPITE ALL EFFORTS THE WIRE REFUSED TO BUDGE. EVENTUALLY WITH TIME AND EFFORT THE WIRE CAME LOOSE AND THE OUTER "WRAP" OF WIRE WAS FOUND TO BE FRAYED AND SEPARATED FROM THE WIRE CORE. WHEN THE WIRE WAS ABLE TO BE WITHDRAWN, IT WAS NOTICED A PORTION OF THE WIRE WAS MISSING AND RETAINED IN THE PATIENT. ULTRASOUND AND FLOURO WERE USED TO CONFIRM THIS, AND THE FRAGMENT APPEARED TO BE STUCK IN THE SOFT TISSUE BETWEEN THE VEIN WALL AND THE SKIN. THE PROVIDER DETERMINED TO NOT ATTEMPT TO REMOVE THE FRAGMENT DUE TO ITS LOCATION WITHIN THE VEIN LUMEN AND BEHIND THE CLAVICLE, AND THE RISK OUTWEIGHED THE BENEFIT OF REMOVING.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15412165 ↗
• MalfunctionSep 13, 2022Fracture; Fracture

  IT WAS REPORTED BY THE PROVIDER THAT THE PATIENT'S RIGHT IJV VEIN WAS ACCESSED EASILY WITH THE NEEDLE WITH EXCELLENT BLOOD RETURN.THE MICRO-WIRE WAS ADVANCED ASSURING BEVEL IN THE "UP" POSITION. THE WIRE WAS THEN FOUND TO BE COILED IN THE VEIN SO WAS WITHDRAWN. ON WITHDRAWAL, THE WIRE "JAMMED" IN THE NEEDLE. THE NEEDLE WAS THEN BACKED OUT SLOWLY AS THE WIRE WOULD NOT MOVE AND THE WIRE WAS DISSECTED FREE FROM ANY SURROUNDING TISSUE DIRECTLY AT THE PUNCTURE. DESPITE ALL EFFORTS THE WIRE REFUSED TO BUDGE. EVENTUALLY WITH TIME AND EFFORT THE WIRE CAME LOOSE AND THE OUTER "WRAP" OF WIRE WAS FOUND TO BE FRAYED AND SEPARATED FROM THE WIRE CORE. WHEN THE WIRE WAS ABLE TO BE WITHDRAWN, IT WAS NOTICED A PORTION OF THE WIRE WAS MISSING AND RETAINED IN THE PATIENT. ULTRASOUND AND FLOURO WERE USED TO CONFIRM THIS, AND THE FRAGMENT APPEARED TO BE STUCK IN A VEIN VALVE. AN ATTEMPT TO REMOVE THE FRAGMENT WAS MADE VIA CUT DOWN, HOWEVER, IT WAS UNSUCCESSFUL AS IT WAS STUCK IN THE TISSUE AND RISK OUTWEIGHED THE BENEFIT OF REMOVING. IT WAS REPORTED THE FRAGMENT WOULD MOST LIKELY NOT BE REMOVED FROM THE PATIENT IN THE FUTURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15412142 ↗
• InjuryFeb 26, 2019Crack; Migration; Crack; Migration

  AS REPORTED ON VOLUNTARY MEDWATCH FORM MW5082549, "DURING A GROSHONG CATHETER PLACEMENT A MINI STICK MAX/COAXIAL MICROINTRODUCER KIT WAS USED. A PORTION OF THE INTRODUCER SHEATH BROKE OFF DURING WITHDRAWAL OVER THE WIRE. THE PORTION RETAINED WAS 8.3CM AS EVIDENCED BY THE REMAINING 1.7CM SHEATH THAT WAS ATTACHED TO THE ORANGE HUB. THE RETAINED PORTION WAS LOCATED IN THE RIGHT ATRIUM WHICH WAS CONFIRMED BY CAT SCAN."

  Patient problems: Foreign Body In Patient

  MAUDE report 8370756 ↗
• InjuryDec 21, 2018Break

  DURING A GROSHONG CATHETER PLACEMENT; A MINI STICK MAX/ COAXIAL MICROINTRODUCER KIT MADE BY (B)(4) WAS USED. A PORTION OF THE INTRODUCER SHEATH BROKE OFF DURING WITHDRAWAL OVER A 0.035 WIRE. THE PORTION RETAINED WAS 8.3 CM AS EVIDENCED BY THE REMAINING 1.7 CM SHEATH THAT WAS ATTACHED TO THE ORANGE HUB. THE RETAINED PORTION WAS LOCATED IN THE RIGHT ATRIUM. CONFIRMED BY CAT SCAN. DATE OF USE: (B)(6) 2018; DIAGNOSIS OR REASON FOR USE: LONG TERM ANTIBIOTIC USE; IS THE PRODUCT COMPOUNDED? NO. IS THE PRODUCT OVER-THE-COUNTER? NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8194420 ↗
• InjurySep 26, 2017Material Fragmentation; Material Fragmentation

  AS REPORTED ON END USER MEDWATCH # (B)(4): "DURING A FEMORAL ACCESS ATTEMPT, A 'MICROPUNCTURE' WIRE WAS INTRODUCED AND RESISTANCE WAS MET. WIRE WAS REMOVED WITH DIFFICULTY. FLUOROSCOPY WAS DONE AND REVEALED POSSIBLE FRACTURE TIP OF WIRE LEFT IN BODY. PHYSICIAN REVEALED TIP HAD BROKEN OFF FROM WIRE." THE WIRE WAS NOT INTRAVASCULAR, BUT LEFT IN THE SOFT TISSUE. THE PHYSICIAN CHOSE NOT TO RETRIEVE THE DEVICE."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6894574 ↗

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-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-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-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-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-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-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-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-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-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-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-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
• 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-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-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