Approach G50793Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00827002507937), received between Jun 23, 2016 and Oct 17, 2023 — classified as 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 reports).

1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 8, 2024Open, Classified

   Affected device lots have labels that state the incorrect expiration dates.

   Z-0346-2025 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2023Unraveled Material; Unraveled Material

  AS REPORTED, DURING A PROCEDURE INVOLVING INTERVENTION OF THE SUPERFICIAL FEMORAL ARTERY, THE TIP OF AN APPROACH CTO MICROWIRE WIRE GUIDE UNRAVELED. ACCESS WAS OBTAINED THROUGH THE POSTERIOR TIBIAL ARTERY TO TREAT THE CHRONIC TOTALLY OCCLUDED (CTO) SUPERFICIAL FEMORAL ARTERY. THE PATIENT'S ANATOMY WAS CALCIFIED. THE WIRE WAS FULLY ADVANCED THROUGH A COOK CXI CATHETER AND UPON MOVING THE WIRE "IN AND OUT OF THE CATHETER" THE TIP SEPARATED BUT DID NOT DETACH. THE WIRE WAS REMOVED AND REPLACED WITH ANOTHER WIRE GUIDE. PER THE REPORTER, RESISTANCE WAS NOT FELT UPON INSERTION OF THE WIRE; HOWEVER, RESISTANCE WAS FELT WHILE ADVANCING THROUGH THE CTO. THE WIRE WAS NOT ALTERED PRIOR TO USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950938 ↗
• MalfunctionOct 3, 2023Material Separation; Difficult to Advance; Scratched Material; Material Separation; Difficult to Advance; Scratched Material

  AS ORIGINALLY REPORTED, DURING AN INTERVENTIONAL PROCEDURE OF THE SUPERFICIAL FEMORAL AND POSTERIOR TIBIAL ARTERIES, THE TIP OF AN APPROACH CTO MICROWIRE WIRE GUIDE 'SEPARATED' WITHIN A CHRONIC, TOTALLY OCCLUDED LESION (100% OCCLUDED) IN THE POSTERIOR TIBIAL ARTERY. THE WIRE WAS NOT ALTERED PRIOR TO USE. THE PATIENT'S ANATOMY WAS CALCIFIED, AND RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE WIRE INTO THE LESION. ALTHOUGH THE WIRE TIP 'SEPARATED', THE TIP REPORTEDLY DID NOT BREAK OFF. A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE. DURING THE SAME PROCEDURE, A MICRO BALLOON WAS UNABLE TO CROSS A LESION AND ANOTHER BALLOON RUPTURED IN THE SUPERFICIAL FEMORAL ARTERY AFTER AN ATHERECTOMY WAS PERFORMED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE TIP OF THE WIRE WAS DAMAGED, WITH PARTIAL SEPARATION OF THE GREEN COATING ON THE DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862824 ↗
• InjuryDec 28, 2021Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  AS REPORTED VIA A MEDWATCH REPORT, DURING AN UNSPECIFIED PROCEDURE, AN APPROACH CTO MICROWIRE WIRE GUIDE KINKED AND BECAME STUCK IN THE VESSEL. AN UNKNOWN ANGIOPLASTY BALLOON AND SHEATH WERE USED WITH THE WIRE. "PART WAY" THROUGH THE PROCEDURE, THE WIRE BENT AND WAS UNABLE TO BE WITHDRAWN FROM THE PATIENT. AN UNKNOWN 6 FRENCH CATHETER WAS ADVANCED IN AN ATTEMPT TO STRAIGHTEN THE KINK IN THE WIRE; HOWEVER, THIS WAS UNSUCCESSFUL. THE SURGEON THEN DECIDED TO PERFORM A CUT-DOWN OF THE LEFT GROIN TO AVOID DAMAGING THE VESSELS OR EQUIPMENT, AND THE WIRE WAS REMOVED UNDER DIRECT VISUALIZATION. THERE HAVE BEEN NO REPORTED ADVERSE EFFECTS TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094625 ↗
• MalfunctionAug 27, 2021Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377187 ↗
• InjurySep 11, 2020Fracture; Material Frayed; Material Separation; Fracture; Material Frayed; Material Separation

  THE PATIENT HAD REQUIRED EXTENSIVE PAD, ANOTHER ATTEMPT TO REOPEN THE CTO OF THE SFA, AND AN INSTENT RESTENOSIS BEFORE THIS PROCEDURE. THE WIRE GUIDE BROKE INSIDE THE PATIENT AND A FRAGMENT OF THE WIRE WAS LEFT INSIDE THE PATIENT. THE USER DECIDED NOT TO REMOVE IT BECAUSE THE PATIENT MIGHT NEED TO HAVE BYPASS SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 10521770 ↗
• MalfunctionJul 1, 2020Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL INFORMATION RECEIVED 21AUG2020. THE HYDROPHILIC COATING OF THE DEVICE WAS ACTIVATED WITH SALINE-WETTED GAUZE IMMEDIATELY BEFORE EACH OF TWO USES DURING THE PROCEDURE. LATEX GLOVES WERE WORN. THE WIRE WAS NOT KEPT HYDRATED WHEN NOT IN USE. GREEN MATERIAL FLAKED FROM THE DEVICE, LEAVING METAL EXPOSED. THE DEVICE WAS USED VIA FEMORAL ACCESS THROUGH A TOTALLY OCCLUDED ANTERIOR TIBIAL ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10219047 ↗
• InjuryMay 11, 2020Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED. THE TIP OF THE WIRE WAS SHAPED PRIOR TO INSERTION INTO THE PATIENT. THE TIP OF THE SEPARATED WIRE WILL BE LEFT IN PLACE; NO ADDITIONAL PROCEDURES WERE PERFORMED.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10043407 ↗
• MalfunctionJun 4, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 8667977 ↗
• MalfunctionJun 4, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8666823 ↗
• MalfunctionMay 17, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8620973 ↗
• MalfunctionMay 13, 2019Material Separation; Material Separation

  IT WAS REPORTED, A PATIENT OF UNKNOWN GENDER OR AGE, WAS UNDERGOING A PERIPHERAL ARTERY DISEASE (PAD) ANGIOPLASTY LEG PROCEDURE. TWO APPROACH CTO MICROWIRE WIRE GUIDES FROM DIFFERENT LOTS WERE USED AND BOTH TIPS STARTED TO UNRAVEL DURING ENTRY AND MANIPULATION THROUGH A .014 CXI CROSSING CATHETER. THE TIPS WERE STILL INTACT BUT PARTIALLY SEPARATED. RIGHT LEG FEMORAL WAS THE ACCESS POINT WHERE THE DEVICES WERE INTRODUCED . HEAVY CALCIFICATION WAS PRESENT IN VESSEL TO BE TREATED. A THIRD CTO WIRE WAS USED WITHOUT ANY ISSUES. THE PROCEDURE WAS COMPLETED WITH NO PATIENT ADVERSE EFFECT OR ADDITIONAL PROCEDURES REQUIRED. PLEASE SEE REPORT REFERENCE NUMBER 1820334-2019-01136 FOR THE OTHER DEVICE MENTIONED HERE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8604608 ↗
• MalfunctionSep 27, 2018Difficult to Remove; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHILE THE APPROACH CTO MICROWIRE WIRE GUIDE WAS BEING ADVANCED INTO THE ANTERIOR TIBIAL ARTERY (ATA), IT STOPPED ADVANCING AND BECAME STUCK WITHIN THE CATHETER. IT COULD NOT BE REMOVED ALONE, SO THE WIRE AND CATHETER WERE REMOVED TOGETHER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SET OF DEVICES. IT WAS LATER FOUND THAT THE WIRE WAS DAMAGED AND PARTIALLY UNRAVELED NEAR THE DISTAL TIP. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7914477 ↗
• MalfunctionDec 12, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SUPERFICIAL FEMORAL ARTERY (SFA) ANGIOPLASTY, WHILE ADVANCING THE APPROACH CTO MICROWIRE WIRE GUIDE INTO THE SHEATH, THE COATING WAS OBSERVED TO BE COMING OFF. THE WIRE GUIDE WAS EXCHANGED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7110697 ↗
• InjuryJul 26, 2017Material Separation; Material Separation

  IT IS ALLEGED THAT AN APPROACH CTO MICROWIRE WIRE GUIDE WAS BEING USED IN THE SUPERFICIAL FEMORAL ARTERY OF A PATIENT WHEN THE TIP OF THE WIRE BROKE OFF. IT WAS REPORTED THAT THE PATIENT HAD NOTICEABLE CALCIFICATION AND AFTER SHAPING THE TIP OF THE WIRE, THE TIP SEPARATED AND WAS "LOST" IN THE CALCIFICATION. THE FRACTURED PIECE OF THE WIRE WAS UNABLE TO BE RETRIEVED. AS PER THE COMPANY REPRESENTATIVE, THE PHYSICIAN WAS NOT ABLE TO REACH THE LESION DUE TO THE CALCIFICATION, AND THE PATIENT RECEIVED A VASCULAR BYPASS AS A RESULT. NO ADVERSE EVENTS HAVE BEEN REPORTED REGARDING THIS INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6744518 ↗
• InjuryJul 19, 2017Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A RIGHT LEG LOWER EXTREMITY ANGIOGRAM PROCEDURE WITH AN APPROACH CTO MICROWIRE WIRE GUIDE, THE TIP SEPARATED. THE PHYSICIAN WAS TRYING TO CROSS A HIGHLY CALCIFIED LESION IN THE POPLITEAL ARTERY. THE WIRE WENT SUBINTIMAL. IT WAS NOW OUTSIDE THE ARTERY. WHEN THE PHYSICIAN PULLED IT BACK, THE TIP SEPARATED. THIS LEFT ABOUT 15 MM OF THE WIRE INSIDE THE PATIENT. THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE IT. THE UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT UNDERGO ANY ADDITIONAL PROCEDURES AND NO ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6724444 ↗
• InjuryNov 10, 2016Material Separation; Material Separation

  WHEN TRYING TO CROSS THE OCCLUSION WITH WIRE AND CATHETER, WHILE SPINNING THE WIRE IN A TIGHT OCCLUSION AND UPON REMOVING CATHETER, THE WIRE FELT STUCK. RESISTANCE WAS SUDDENLY NO LONGER FELT, AND UPON REMOVING CATHETER, IT WAS NOTED THAT THE WIRE BROKE AND DETACHED INSIDE THE PATIENT'S ARTERY. THE WIRE WAS RETRIEVED WITH A FORCEP.

  Patient problems: No Code Available

  MAUDE report 6094169 ↗
• InjuryJun 23, 2016Material Separation; Material Separation

  DURING A PAD PROCEDURE THE WIRE TIP SEPARATED WHILE CROSSING THE LESION. THE TIP REMAINED IN THE PATIENT BUT WAS ABLE TO BE SNARED AND REMOVED. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5744470 ↗