AngioDynamics 45759Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI H965457590), received between Sep 13, 2016 and Feb 4, 2026 — classified as 12 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Fracture; Detachment of Device or Device Component

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75". DURING A CARDIAC PROCEDURE, WHILE THE SHEATH WAS INSIDE THE PATIENT, THE HUB OF THE SHEATH DETACHED CAUSING THE WHITE PORTION OF THE SHEATH TO REMAIN INSIDE OF THE PATIENT. VASCULAR SURGERY WAS CALLED TO ASSIST IN RETRIEVING THE SHEATH FROM THE PERIPHERAL VASCULAR SYSTEM. THE PROCEDURE WAS COMPLETED AFTER RETRIEVAL OF THE SHEATH. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24261737 ↗
• MalfunctionDec 3, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  ANGIODYNAMICS RECEIVED NOTIFICATION OF AN EVENT FROM THE FDA REGARDING A MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75". A PATIENT WITH A DIAGNOSIS OF ATHEROSCLEROSIS OF THE LEFT LOWER EXTREMITY WITH FIRST TOE ULCERATION WAS ADMITTED FOR A LEFT TRANSPOPLITEAL SUPERFICAL FEMORAL ARTERY INTERVENTION. A COAXIAL MICROINTRODUCER (MINI STICK MAX) WAS USED IN THE PROCEDURE. DURING THE PROCEDURE, A PORTION (7.62CM) OF THE CATHETER [SHEATH TUBING] BROKE OFF AND BECAME LODGED IN THE TISSUE SURROUNDING THE ARTERY. THE OBJECT COULD NOT BE REMOVED WITHOUT A SURGICAL PROCEDURE. THE PATIENT ELECTED TO NOT HAVE THE OBJECT REMOVED.

  Patient problems: Infiltration into Tissue

  MAUDE report 23708331 ↗
• MalfunctionApr 4, 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 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" KIT. DURING AN ANGIOGRAM PROCEDURE, THE GUIDEWIRE FROM THE MICROPUNCTURE KIT BROKE OFF IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WAS NO REPORT OF PATIENT HARM BY THE END USER. DESPITE MULTIPLE GOOD FAITH EFFORT ATTEMPTS, NO FURTHER DETAILS HAVE BEEN OBTAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21773371 ↗
• MalfunctionApr 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ANGIODYNAMICS REGIONAL BUSINESS MANAGER REPORTED AN ISSUE WITH A MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG. DURING REMOVAL, THE DEVICE "CAME APART" WHEN REMOVING FROM THE PATIENT'S BODY. IT WAS REPORTED THAT IT LOOKS AS IF THE SHEATH PORTION ( 0.035 10CM WHITE PART) IS NO LONGER ATTACHED TO THE HUB. THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072505 ↗
• MalfunctionJun 6, 2023Fracture; Fracture

  AN END USER EXPERIENCED AN ISSUE WHEN USING A GUIDEWIRE FROM A MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" KIT. IT WAS REPORTED THE MICRO ACCESS GUIDEWIRE BROKE APART INSIDE THE PATIENT. BOTH PIECES WERE SAFELY REMOVED FROM THE PATIENT. IT WAS REPORTED THE PATIENT WAS NOT COOPERATIVE, SO THE PROCEDURE WAS ABORTED AFTER THE WIRE WAS RETRIEVED WITH A SNARE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17071841 ↗
• MalfunctionNov 14, 2022Fracture; Fracture

  VOLUNTARY MDR REPORT: MW5112877. AN END USER REPORTED AN ISSUE WITH A MINI STICK MAX 5F X 10CM STIFF .018 NI/TU ECHO 2.75" PG. THE FOLLOWING WAS REPORTED: "PATIENT WAS BROUGHT TO THE ANGIOGRAPHY SUITE AND PLACED IN SUPINE POSITION. INITIALLY TRANSDURAL APPROACH WAS ATTEMPTED, AND AFTER RADIAL ARTERY WAS IDENTIFIED USING ULTRASOUND GUIDANCE AND THE OVERLYING SKIN WAS INFILTRATED WITH 2CC OF 1% LIDOCAINE, NEXT ARTERY WAS ACCESSED WITH A MICRO-PUNCTURE NEEDLE UNDER DIRECT ULTRASOUND GUIDANCE AND A MICRO-WIRE WAS ADVANCED THROUGH THE NEEDLE, HOWEVER THE MICRO-WIRE APPEARED TO GET STUCK, AND NOT ADVANCING FORWARD NOR BACKWARDS. AS THE MICRO-WIRE WAS PULLED BACK GENTLY WITH THE NEEDLE, IT WAS NOTICED THAT THE TIP OF THE MICROWIRE BROKE OFF AND GOT RETAINED. SUBSEQUENT RIGHT DISTAL FOREARM X-RAY SHOWED MICRO-WIRE POSITION IN THE SOFT TISSUE, HOWEVER INTERVENTIONALIST COULD NOT CONFIRM IF IT WAS INTRAVASCULAR. PATIENT HAND WAS MONITORED FOR SEVERAL MINUTES AND THERE WAS NO EVIDENCE OF ISCHEMIA OR SWELLING. THIS UNINTENDED COMPLICATION WAS COMMUNICATED WITH THE PATIENT IN DETAIL, WAS MADE AWARE OF THE SMALL PART OF WIRE THAT REMAINED AND WAS SHOWN THE PICTURES AT THE END OF THE PROCEDURE. T

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15790705 ↗
• MalfunctionMay 26, 2022Fracture; Fracture

  WHEN PLACING THE INTRODUCER SHEATH FROM A MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" KIT, THE PHYSICIAN USED A SCALPEL TO WIDEN THE ACCESS SITE. HE REPORTED THAT HE MAY HAVE TOUCHED THE SHAFT WITH THE SCALPEL BUT CAN NOT CONFIRM. THE PHYSICIAN WAS EXCHANGING THE WIRE AND FELT THE WIRE SNAG. IT WAS POSSIBLE IT WAS SNAGGED AGAINST CALCIFIED TISSUE. WHEN HE PUSHED AGAIN, THE SHEATH BROKE COMPLETELY AWAY FROM THE HUB. THEY SPENT AN HOUR FISHING THE SHAFT OF THE SHEATH OUT OF THE PATIENT USING A CUT DOWN, PLACING A LARGER , 7F SHEATH, AND THEN A SNARE THROUGH THAT SHEATH TO SNAG THE SHAFT. A SECOND DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14518086 ↗
• MalfunctionFeb 17, 2022Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A MINI STICK MAX 5F X 10CM KIT. DURING INTRODUCTION, THE END USER ATTEMPTED TO GAIN ACCESS IN THE PATIENT'S RIGHT FEMORAL VEIN. THE NEEDLE AND GUIDEWIRE WERE INSERTED WITHOUT INCIDENT; HOWEVER, THE SHEATH/DILATOR WOULD NOT ADVANCE INTO THE VESSEL. THE DILATOR WAS REMOVED FROM THE SHEATH AND ADVANCED OVER THE WIRE BUT WOULD NOT ENTER THE VESSEL. THE DILATOR WAS THEN REINSERTED INTO THE SHEATH AND THE ASSEMBLY WAS ADVANCED OVER THE WIRE BUT, AGAIN, WOULD NOT GO INTO THE VESSEL. WHEN REMOVING THE ASSEMBLED SHEATH/DILATOR, OVER THE WIRE, THE TIP SHEARED OFF AND WAS RECOVERED OUTSIDE THE PATIENT. ANOTHER SAME KIT WAS OPENED TO ATTEMPT ACCESS BUT WAS ALSO UNSUCCESSFUL. AT THIS TIME, THE END USER CHOSE TO TRY A MEDLINE MICROPUNCTURE KIT BUT THIS WAS UNSUCCESSFUL AS WELL; THEREFORE, THE CASE WAS CANCELLED BECAUSE ACCESS COULD NOT BE ACHIEVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549901 ↗
• MalfunctionJan 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A MINI STICK MAX 5F X 10CM. DURING A PROCEDURE, THE MICROPUNCTURE WIRE WAS INSERTED THROUGH THE NEEDLE AND THE WIRE PROLAPSE. WHEN THE WIRE WAS PULLED OUT OF THE BODY, THE SOFT TIP REMAINED IN THE PATIENT; THE WIRE HAD NOT BEEN PULLED BACK AGAINST THE ACCESS NEEDLE. THE TIP OF THE WIRE WAS RETRIEVED VIA A SMALL INCISION ASSISTED WITH HEMOSTATS. A NEW WIRE WAS PLACED AND THE PROCEDURE WAS 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: Device Embedded In Tissue or Plaque

  MAUDE report 13237912 ↗
• MalfunctionDec 6, 2021Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A MINI STICK MAX 5F X 10CM STIFF .018 NI/TU ECHO2.75" PG. THE FOLLOWING WAS REPORTED: ON (B)(6) 2021 THE TREATING PHYSICIAN ATTEMPTED TO ACCESS THE PATIENT'S RIGHT FEMORAL ARTERY WITH A MINI STICK MAX KIT. DUE TO SCAR TISSUE, THE PATIENT WAS KNOWN TO BE CHALLENGING TO ACCESS. THE NEEDLE WAS PLACED IN THE ARTERY FOLLOWED BY THE .018 WIRE. THE NEEDLE WAS REMOVED AND THE SHEATH DILATOR WAS ATTEMPTED TO ADVANCE, BUT WOULD NOT ENTER THE VESSEL. THE DILATOR WAS ABLE TO PASS ALONE, BUT NOT WHEN ASSEMBLED WITH THE SHEATH. AFTER DAMAGING THE SHEATH, ANOTHER KIT WAS OPENED AND THE SAME STEPS REPEATED UNSUCCESSFULLY. THE NITINOL WIRE WAS REPLACED WITH A NIT-VU WIRE WHICH DID NOT HELP. THE NIT-VU WIRE WAS REPLACED WITH A V-18 CONTROL WIRE, AND AT THIS TIME IT WAS NOTICED ON FLUORO THAT THERE WAS PART OF ANOTHER WIRE FREE-FLOATING IN THE VESSEL. VISUAL INSPECTION CONFIRMED THAT THE NITINOL WIRE FROM THE ORIGINAL MINI STICK MAX KIT HAD BROKEN IN THE MANDREL PORTION AND REMAINED IN THE PATIENT. A MEDLINE MICRO-PUNCTURE KIT WAS USED TO SUCCESSFULLY ACCESS THE PATIENT AND A SNARE WAS USED TO REMOVE THE NITINOL WIRE FRAGMENT. THE FRAGMENT WAS DISCARDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12933218 ↗
• InjuryAug 10, 2021Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED THE FOLLOWING EVENT WITH A MINI STICK MAX 5F X 10 CM STIFF.018 NI/TU ECHO 2.75: I MET WITH A RADIOLOGY STUDENT. HE WAS USING OUR MINISTICK MAX MICRO-PUNCTURE KIT FOR A CHEST TUBE PLACEMENT. HE INSERTED THE NEEDLE, THEN THE WIRE, THEN PULLED THE NEEDLE, THEN PLACED THE SHEATH SUCCESSFULLY. HE THEN TRIED TO PULL THE INNER DILATOR AND WIRE OUT AT THE SAME TIME AND IT WOULD NOT COME OUT. AFTER THAT, THE INTERVENTIONAL RADIOLOGIST, TOOK OVER AND PULLED OUT THE WIRE AND DILATOR. HE NOTICED THAT THE FLOPPY END OF THE WIRE HAD COME OFF AND WAS LEFT INSIDE THE PATIENT. THEY CONFIRMED THIS ON FLUOROSCOPY. NEXT STEP, THEY PULLED THE SHEATH OUT OF THE BODY. THE PATIENT HAD TO THEN COME BACK TO HAVE THE WIRE REMOVED VIA CUT DOWN IN THE SOFT TISSUE. THE CUT DOWN WAS APPROXIMATELY 2CM AND REQUIRED SUTURES. THE WIRE FRAGMENT HAD NOT MIGRATED. THIS WAS SUCCESSFUL; ALL WIRE WAS REMOVED. TO BE SPECIFIC, THE WIRE WAS LEFT IN THE PATIENT DURING ACCESS FOR THE CHEST TUBE ON (B)(6) 2021. THE CUT DOWN TO RETRIEVE THE WIRE WAS DONE ON (B)(6) 2021. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12299946 ↗
• InjuryJan 18, 2021Fracture; Fracture

  AN END USER REPORTED AN INCIDENT WITH A MINI STICK MAX KIT. DURING A PROCEDURE, THE WIRE BROKE OFF INSIDE OF THE PATIENT. IR SUCCESSFULLY SNARED THE TIP FROM THE PATIENT AND THE PATIENT WAS KEPT OVERNIGHT IN THE HOSPITAL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11185487 ↗
• MalfunctionFeb 21, 2020Fracture; Fracture

  AS REPORTED BY THE END USER: I USED A DEFECTIVE MICROPUNCTURE SHEATH YESTERDAY. THE LUER LOCK PART OF THE INNER DILATOR SNAPPED OF AFTER WE INTRODUCED TO THE BODY. ITEM NUMBER IS 45-759 L: 5544060. THE INTRODUCER SHAFT REMAINED IN THE PATIENT. THE PIECE WAS RETRIEVED, THE METAL PART OF THE INNER DILATOR IS STILL ON THE MICRO WIRE. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. IT WAS CONFIRMED THAT THE PATIENT WAS NOT HARMED. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9740567 ↗
• InjuryFeb 21, 2020Fracture; Fracture

  AS REPORTED: WE WERE TRYING TO GAIN ACCESS TO DO A FISTULAGRAM WITH THE 5FR MICRO, WHEN THE FLOPPY END OF THE WIRE BROKE OFF IN THE PATIENTS ARM. THE DOCTOR WAS ABLE TO RETRIEVE THE WIRE VIA CUTDOWN. THE PATIENT WAS REPORTED AS STABLE POST PROCEDURE. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9740543 ↗
• InjuryFeb 12, 2020Fracture; Fracture

  USER MEDWATCH (B)(4) RECEIVED FROM FDA ON 22-JAN-2020: ELDERLY MALE WITH END STAGE RENAL DISEASE AND ON DIALYSIS, WHILE HAVING A HEART CATHETER: "MINI STICK MAX MICROPUNCTURE WIRE SHEARED OFF INTO PATIENT'S RIGHT GROIN WHEN ACCESSING VEIN. DOCTOR WAS ABLE TO SNARE WIRE. WIRE WAS RETRIEVED SUCCESSFULLY UNDER FLUOROSCOPY. NO COMPLICATIONS PRESENT FOR THE PATIENT." "PATIENT HAD THICK SKIN. WE TRIED GET MICRO-PUNCTURE ACCESS WHICH WAS SUCCESSFUL. HOWEVER, COULDN'T GET THE MICROPUNCTURE SHEATH OVER THE WIRE. WE TRIED TO ABORT THE ACCESS BY TAKING OUT WIRE AND NOTICED MICROPUNCTURE WIRE BROKE WITH EMBOLIZED PIECE IN THE RIGHT FEMORAL VEIN, HELD IN PLACE WITH MANUAL PRESSURE ON THE GROIN. WE TOOK ACCESS IN THE RIGHT INTERNAL JUGULAR VEIN AND TRIED TO SNARE THE WIRE, WHICH WAS UNSUCCESSFUL AND LATER TOOK ACCESS IN THE LEFT CFV AND SUCCESSFULLY SNARED THE WIRE OUT." ORIGINAL INTENDED PROCEDURE WAS HEART CATH. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9699585 ↗
• InjuryJan 22, 2020Fracture; Fracture

  RECEIVED USER MEDWATCH FROM ANGIODYNAMICS' CUSTOMER ON JANUARY 10 2020, REFERENCE NUMBER (B)(4). PER THE REPORT EVENT DESCRIPTION: FRACTURE OF MINI STICK MAX WIRE DURING CASE, HAD TO BE SNARED AND RETRIEVED. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9617317 ↗
• InjuryDec 30, 2019Fracture; Fracture

  AS REPORTED: PROCEDURE: LEFT HEART CATH, GAINING MICROPUNCTURE ACCESS. HUB DETACHED FROM SHEATH LEAVING SHEATH INSIDE PATIENTS RIGHT FEMORAL ARTERY. THEY HAD TO DO A CUT-DOWN IN ORDER TO REMOVE SHEATH FROM PATIENTS BODY. IT WAS REPORTED THE PATIENT DID NOT SUFFER ANY PERMANENT HARM OR INJURY DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9530388 ↗
• InjuryDec 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  RECEIVED MEDWATCH LETTER REFERENCNG USER MEDWATCH (B)(4) FROM FDA JANUARY 20 2020. NEW INFORMATION: AN ELDERLY FEMALE PATIENT HAS A HISTORY OF AORTIC STENOSIS AND CORONARY ARTERY DISEASE (CAD). WHILE PERFORMING PREP FOR TVAR PROCEDURE, THE MICRO-PUNCTURE SHEATH HUB BECAME SEPARATED FROM THE SHEATH AND LODGED IN PATIENT'S LEFT FEMORAL GROIN SITE. BY ACCESSING THE RIGHT GROIN, BROKEN SHEATH WAS THEN RETRIEVED USING A GUIDEWIRE. TRANSCATHETER AORTIC VALVE REPLACEMENT (TVAR) PROCEDURE WAS ABORTED. PATIENT WAS DISCHARGED HOME. "SHORT HISTORY: THE PATIENT CAME IN FOR A TRANSVASCULAR CATHETER AORTIC VALVE REPLACEMENT. THE PATIENT'S SHEATH AFTER ACCESS INTO THE LEFT GROIN WAS FOUND TO BE EMBOLIZED AND BROKEN. ON FLOUROSCOPY EXAMINATION, IT WAS FOUND TO BE IN THE COMMON FEMORAL ARTERY OF THE LEFT SIDE. MANUAL HEMOSTASIS WAS APPLIED TO MAKE SURE THAT THE PATIENT DOES NOT BLEED AS WELL AS THE SHEATH DOES NOT MOVE. I HAD BEEN CALLED TO EVALUATE THE PATIENT IN THIS UNFORTUNATE CIRCUMSTANCE AND THE POSSIBILITY TO RETRIEVE THE DEVICE. OPERATIVE DETAIL: ACCESS WAS TAKEN IN THE RIGHT GROIN AND BY THE MICROPUNCTURE SHEATH, AND ULTRASOUND AND WE UPSIZED IT FOR AN 8-FRENCH ARROW SHEATH 25CM. SUBSEQUEN

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9415539 ↗
• InjuryAug 7, 2019Fracture; Fracture

  AS REPORTED, " DR (B)(6) WAS USING THE MINI STICK MAX. HE INSERTED NEEDLE, WIRE, THEN SHEATH. AS HE PUSHED DOWN ON THE SHEATH HE THINKS THERE WAS A KINK AND AS THE WIRE WAS PULLED BACK ONLY HALF WAS PRESENT. THE OTHER HALF WAS IN THE FEMORAL VEIN IN WHICH THEY HAD TO DO A CUT DOWN FOR EXTRACTION. THE ENTIRE WIRE WAS ABLE TO BE REMOVED." THE USED DEVICE HAS BEEN RETURNED TO ANGIODYANMICS.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8870370 ↗
• InjuryJul 2, 2018Crack; Crack

  AS REPORTED, REGARDING MINISTICK, "DURING ATTEMPTS AT FEMORAL ACCESS, THE PHYSICIAN ATTEMPTED TO REMOVE THE WIRE AND NEEDLE TO RE-ATTEMPT. WHILE PULLING BACK, RESISTANCE WAS MET AND AS HE BEGAN PULLING SLIGHTLY MORE, THE WIRE TIP BROKE OFF INSIDE THE SUBCUTANEOUS TISSUE." NO PATIENT COMPLICATIONS WERE REPORTED. THE USED DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 7655385 ↗
• InjuryJun 13, 2018Crack; Crack

  AS REPORTED, DURING A LEFT HEART CATHETERIZATION THE PHYSICIAN PULLED THE WIRE BACK THRU THE NEEDLE AND SEVERED THE TIP OF THE WIRE INSIDE THE PATIENT. THE LENGTH OF THE WIRE STILL INSIDE THE PATIENT WAS APPROX. 1.5 CM. THE WIRE WAS DISCARDED. A VASCULAR SURGEON WAS CONSULTED AND THE PHYSICIAN IS CONSIDERING LEAVING THE WIRE INSIDE THE PATIENT. THE PATIENT'S CONDITION IS LISTED AS "OK."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7596563 ↗
• MalfunctionMay 17, 2017Crack; Crack

  AS REPORTED, MINI STICK MAX DILATOR HUB DETACHED WHILE THE SHEATH WAS IN THE PATIENT'S VEIN. THE DEVICE WAS ABLE TO BE REMOVED IN IT'S ENTIRETY AND THE PATIENT CONDITION WAS "UNAFFECTED." A NEW SHEATH WAS USED AND THE PROCEDURE CONTINUED. IT HAS BEEN INDICATED THAT THE DAMAGED SHEATH WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6571961 ↗
• InjuryOct 25, 2016Material Fragmentation; Material Fragmentation

  AS REPORTED ON USER MEDWATCH MW5064763 : "DURING ATTEMPTED PERIPHERAL ARTERY ANGIOPLASTY OF LEFT FEMORAL ARTERY, ARTERY WAS ACCESSED UTILIZING THE MICROPUNCTURE TECHNIQUE. IT WAS DIFFICULT TO PLACE THE MICROPUNCTURE SHEATH OVER THE GUIDEWIRE INTO VESSEL. THE GUIDEWIRE ACTUALLY BROKE WITH PART BEING RETAINED IN THE ILIAC ARTERY. THE COMMON FEMORAL ARTERY WAS RE-ACCESSED BY GAINING ENTRY INTO THE VESSEL. A 4 FRENCH ANGLED GLIDE CATHETER AND A 2MM MICRO SNARE KIT WAS USED TO RETRIEVE THE BROKEN WIRE. THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT. " THE FORM, AS RECEIVED FROM THE FDA, DID NOT HAVE ANY IDENTIFYING OR CONTACT INFORMATION REGARDING THE COMPLAINT REPORTER. (B)(4) SHIPPING HISTORY FOR THE REPORTED LOT NUMBER INDICATES THAT THE LOT OF PRODUCT WAS DISTRIBUTED TO MORE THAN 20 DIFFERENT HOSPITALS. IT IS THEREFORE NOT POSSIBLE TO CONTACT THE COMPLAINT REPORTER REGARDING WHETHER THE DEVICE SAMPLE CAN BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 6053372 ↗
• InjurySep 13, 2016Break; Material Separation

  DURING ATTEMPTED PERIPHERAL ARTERY ANGIOPLASTY OF LEFT FEMORAL ARTERY, WAS ACCESSED UTILIZING THE MICROPUNCTURE TECHNIQUE. IT WAS DIFFICULT TO PLACE THE MICROPUNCTURE SHEATH OVER THE GUIDEWIRE INTO VESSEL. THE GUIDEWIRE ACTUALLY BROKE WITH PART BEING RETAINED IN THE ILIAC ARTERY. THE COMMON FEMORAL ARTERY WAS RE-ACCESSED BY GAINING ENTRY INTO THE VESSEL. A 4-FRENCH ANGLED GLIDE CATHETER AND A 2MM MICRO SNARE KIT WAS USED TO RETRIEVE THE BROKEN WIRE. THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 5952310 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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