Approach G52939Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00827002529397), received between Dec 5, 2016 and Oct 16, 2025 — classified as 14 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (15 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-0347-2025 · Root cause: Labeling Change Control · FDA record ↗

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.

• InjuryOct 16, 2025Break; Break

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

  Patient problems: Foreign Body In Patient

  MAUDE report 23312333 ↗
• InjuryNov 19, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 14JAN2025. ACCESS WAS OBTAINED IN THE COMMON FEMORAL ARTERY TO TARGET THE PERONEAL ARTERY, WHICH WAS STENOSED AND CALCIFIED. THE WIRE WAS NOT ALTERED PRIOR TO USE, AND "NOT A LOT" OF RESISTANCE WAS ENCOUNTERED DURING INSERTION OF THE WIRE. THE WIRE WAS NOT PULLED OR MANIPULATED BACKWARDS THROUGH A NEEDLE OR OTHER METAL INSTRUMENT. THE TIP OF THE WIRE SEPARATED UPON REMOVAL OF THE DEVICE. THE SEPARATED FRAGMENT REMAINS IN THE PERONEAL ARTERY, AS IT COULD NOT BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20727764 ↗
• MalfunctionJul 15, 2024Break; Break

  AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOPLASTY AND STENT PLACEMENT WITHIN ANOTHER MANUFACTURER'S STENOSED STENT, THE TIP OF AN APPROACH HYDRO ST MICROWIRE WIRE GUIDE SEPARATED IN THE PATIENT AS THE USER ATTEMPTED TO CROSS THE LESION. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY TO TARGET THE LEFT PLANTAR. THE ANATOMY WAS NOT TORTUOUS, SCARRED, OR CALCIFIED. THE WIRE WAS NOT ALTERED PRIOR TO USE. RESISTANCE WAS ENCOUNTERED AS THE DEVICE WAS USED TO CROSS THE LESION AND AGAIN AS THE WIRE WAS REMOVED THROUGH A CXI CATHETER. THE WIRE WAS NOT MANIPULATED BACKWARDS OR PULLED THROUGH THE NEEDLE. THE SEPARATED WIRE FRAGMENT WAS REMOVED WITH A MICRO SNARE AND THE CATHETER AND WIRE WERE REMOVED. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742432 ↗
• InjuryMay 6, 2024Break; Unraveled Material; Break; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED 02MAY2024. THE WIRE WAS NOT ALTERED PRIOR TO USE. ACCESS WAS OBTAINED IN THE PEDAL AND FEMORAL ARTERIES FOR THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED AS THE WIRE WAS ADVANCED THROUGH THE PEDAL ACCESS SITE. THE ANATOMY WAS CALCIFIED AND HIGHLY STENOSED, WITH SINGLE VESSEL RUNOFF AND CHRONIC TOTAL OCCLUSION IN THE POPLITEAL ARTERY. THE TIP OF THE WIRE SHEARED OFF WHEN IT BECAME CAUGHT BETWEEN THE TIP OF A CXI CATHETER AND PROTRUDING CALCIUM IN THE ANTERIOR TIBIAL ARTERY. RESISTANCE WAS ¿POTENTIALLY¿ ENCOUNTERED UPON REMOVAL OF THE WIRE THROUGH THE CATHETER. THE WIRE WAS NOT REMOVED OR MANIPULATED THROUGH A NEEDLE OR METAL INSTRUMENT DURING THE PROCEDURE. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19254326 ↗
• InjuryOct 23, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED 27OCT2023. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. THE ANATOMY WAS HEAVILY CALCIFIED AND THE DORSALIS PEDIS ARTERY WAS 80% OCCLUDED. THE WIRE WAS NOT ALTERED PRIOR TO USE. RESISTANCE WAS NOT FELT UPON INSERTION OF THE WIRE AND THE WIRE WAS NOT MANIPULATED/PULLED BACKWARD THROUGH THE NEEDLE OR ANY OTHER METAL INSTRUMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17986636 ↗
• MalfunctionAug 8, 2023Material 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17482339 ↗
• InjurySep 16, 2022Break; Break

  AS REPORTED, AN APPROACH HYDRO ST WIRE SEPARATED DURING AN UNSPECIFIED PROCEDURE. THE DEVICE WAS ADVANCED THROUGH HEAVILY CALCIFIED VESSELS IN AN ATTEMPT TO GO THROUGH AN OCCLUSION. WHEN THE DEVICE WAS WITHDRAWN, THE TIP OF THE DEVICE WAS FOUND TO BE SEPARATED AND STUCK WITHIN THE CALCIFICATION. THE DEVICE TIP WAS UNABLE TO BE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS ABANDONED DUE TO THE INABILITY TO CANNULATE THE VESSEL. THERE HAVE BEEN NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS EVENT. ADDITIONAL EVENT DETAILS HAVE BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15439679 ↗
• MalfunctionAug 24, 2022Break; Stretched; Unraveled Material; Break; Stretched; Unraveled Material

  AS REPORTED, DURING AN UNSPECIFIED "PEDAL CASE" INVOLVING TIBIAL LESIONS, AN APPROACH HYDRO ST MICROWIRE WIRE GUIDE SEPARATED AND FRAYED. PEDAL ACCESS WAS REPORTEDLY DIFFICULT, REQUIRING MULTIPLE ACCESS KITS. THE VESSELS WERE EXTREMELY CALCIFIED, AND RESISTANCE WAS ENCOUNTERED WITH MULTIPLE PRODUCTS DURING THE CASE, INCLUDING THE COMPLAINT DEVICE. THE WIRE GUIDE, WHICH WAS NOT ALTERED PRIOR TO USE, WAS ADVANCED TOWARDS THE TIBIAL PERONEAL TRUNK, AND A COOK PTA BALLOON WAS ADVANCED OVER THE WIRE. AFTER INFLATING THE BALLOON, THE PHYSICIAN ATTEMPTED TO ADVANCE THE WIRE WHILE THE BALLOON WAS STILL INFLATED. THE PHYSICIAN ATTEMPTED TO REMOVE THE WIRE AFTER DEFLATING THE BALLOON; HOWEVER, THE WIRE BECAME STUCK IN THE BALLOON CATHETER AND SUBSEQUENTLY FRAYED AND SEPARATED. THE PHYSICIAN WAS ABLE TO REMOVE THE WIRE, BUT A PIECE OF THE WIRE REMAINED INSIDE THE BALLOON CATHETER. THE PHYSICIAN CUT THE BALLOON CATHETER AND WAS ABLE TO REMOVE THE CATHETER AND WIRE. 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 DU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287147 ↗
• MalfunctionJun 27, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING AN ANGIOGRAM, AN APPROACH HYDRO ST MICROWIRE WIRE GUIDE'S HYDROPHILIC COATING DETACHED AND APPEARED TO BE "FRAYED". ACCESS WAS OBTAINED IN THE GROIN TO TARGET THE SUPERFICIAL FEMORAL ARTERY. THE ANATOMY WAS NOT TORTUOUS OR CALCIFIED. THE WIRE, WHICH WAS NOT ALTERED PRIOR TO USE, WAS FLUSHED WITH HEPARINIZED SALINE TO ACTIVATE THE COATING. THE WIRE WAS USED ONE TIME ONLY. THE COATING DID NOT FLAKE. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14827867 ↗
• MalfunctionApr 23, 2021Peeled/Delaminated; Material Separation; Unraveled Material; Peeled/Delaminated; Material Separation; Unraveled Material

  INFORMATION WAS AVAILABLE AND INADVERTENTLY OMITTED FROM THE INITIAL REPORT. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. LATEX GLOVES WERE WORN AND THE HYDROPHILIC COATING WAS ACTIVATED WITH SALINE AND GAUZE PER "NORMAL PROTOCOL". THE ANATOMY WAS CALCIFIED AND TORTUOUS. ALTHOUGH THE CUSTOMER REPORTED THAT NOTHING REMAINED IN THE BODY, THEY USER IS REPORTEDLY NOT 100% CERTAIN THAT A SMALL PIECE DID NOT REMAIN. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE ON (B)(6) 2021, THE WIRE WAS BROKEN WITH EXPOSURE OF THE MANDRIL AND COIL ELONGATION NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11717567 ↗
• InjuryMay 13, 2020Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Code Available

  MAUDE report 10052006 ↗
• InjuryMay 1, 2020Material Separation; Material Separation

  AS REPORTED, DURING AN UNSPECIFIED RIGHT RENAL INTERVENTION, AN APPROACH HYDRO ST MICROWIRE WIRE GUIDE SEPARATED. ACCESS WAS GAINED IN THE RIGHT FEMORAL ARTERY AND THE PATIENT'S ANATOMY WAS CALCIFIED. RESISTANCE WAS REPORTED UPON REMOVAL OF THE COMPLAINT DEVICE THROUGH AN UNKNOWN CATHETER. THE WIRE REPORTEDLY BECAME CAUGHT IN A COOK FORMULA 418 RENAL BALLOON-EXPANDABLE STENT AND SUBSEQUENTLY SEPARATED AT THE TIP. COOK VASCULAR RETRIEVAL FORCEPS WERE USED TO REMOVE MOST OF THE WIRE; ALTHOUGH, A MINIMAL AMOUNT OF THE SEPARATED WIRE WAS LEFT IN THE PATIENT. THE PHYSICIAN REPORTEDLY FELT THAT IT WAS ACCEPTABLE TO LEAVE THE REMAINING PORTION OF THE DEVICE INSIDE THE PATIENT. THE WIRE WAS NOT NOTED TO BE KINKED, AND IT WAS NOT ALTERED PRIOR TO USE. 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.

  Patient problems: No Code Available

  MAUDE report 10017969 ↗
• MalfunctionApr 20, 2020Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OCCLUDED LEFT POSTERIOR TIBIAL VESSEL, THE OUTER LAYER OF AN APPROACH HYDRO ST MICROWIRE WIRE GUIDE CAME OFF AS THE PHYSICIAN ADVANCED THE DEVICE INTO THE VESSEL. THE USER THEN SWITCHED TO ANOTHER MANUFACTURER'S WIRE AND THE SAME THING HAPPENED TO THAT WIRE. ANOTHER DEVICE OF THE SAME TYPE AS THE COMPLAINT DEVICE WAS THEN OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9978237 ↗
• MalfunctionMar 18, 2020Material 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 9847649 ↗
• InjuryJan 2, 2020Material Separation; Material Separation

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

  Patient problems: Foreign Body In Patient

  MAUDE report 9538273 ↗
• InjurySep 6, 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: Foreign Body In Patient; No Code Available

  MAUDE report 8969248 ↗
• MalfunctionMay 6, 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 8583701 ↗
• InjuryDec 14, 2018Material Separation; Material Separation

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

  Patient problems: Foreign Body In Patient; Loss Of Pulse; No Code Available

  MAUDE report 8164801 ↗
• MalfunctionSep 19, 2018Material Separation; Stretched; Unraveled Material

  THE COMPLAINANT REPORTED THAT THE APPROACH HYDRO ST MICROWIRE WIRE GUIDE WAS USED TO CROSS A CALCIFIED OCCLUSION IN THE PATIENT'S FOOT DURING A TIBIAL ANGIOPLASTY PROCEDURE. THE WIRE STRETCHED AND UNRAVELED UPON REMOVAL. ALL OF THE WIRE WAS REMOVED FROM THE PATIENT. IT WAS FURTHER NOTED THAT THE DISTAL WELD CONNECTION SEPARATED. THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7889799 ↗
• InjuryJun 11, 2018Material Separation; Material Separation

  IT WAS REPORTED, WHILE ATTEMPTING TIBIAL ANGIOPLASTY, THE TIP OF THE APPROACH HYDRO ST MICROWIRE WIRE GUIDE BROKE OFF IN THE PATIENT'S HEAVILY CALCIFIED TIBIAL ARTERY. ANOTHER MANUFACTURER'S WIRE REPORTEDLY ALSO BROKE DURING THE PROCEDURE. THE COMPLAINANT REPORTED THE EVENT WAS MOST LIKELY NOT DUE TO AN ISSUE WITH THE APPROACH HYDRO ST MICROWIRE WIRE GUIDE, BUT RATHER THE HEAVY CALCIFICATION OF THE PATIENT'S ANATOMY. THE PATIENT WAS NOTED TO HAVE "SEVERE DISEASE," AND HAS BEEN " LOSING TOES." THIS PROCEDURE WAS A FINAL EFFORT BEFORE CONSIDERING LIMB AMPUTATION. THE BROKEN DEVICE COMPONENT WAS NOT ABLE TO BE REMOVED AND REMAINS IN THE PATIENT'S FOOT. NO ADDITIONAL PROCEDURES ARE REQUIRED AT THIS TIME. NO ADVERSE EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS OCCURRENCE. THE COMPLAINT DEVICE WAS DISCARDED AT THE USER FACILITY; THEREFORE, IT CANNOT BE RETURNED FOR MANUFACTURER INVESTIGATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 7588761 ↗
• InjuryMar 19, 2018Difficult to Remove; Material Separation; Material Deformation; Difficult to Remove; Material Separation; Material Deformation

  IT WAS REPORTED THAT DURING TREATMENT OF THE LEFT PERONEAL ARTERY, RESISTANCE WAS ENCOUNTERED DURING REMOVAL OF THE APPROACH HYDRO ST MICROWIRE WIRE GUIDE. THE WIRE GUIDE WAS VISUALIZED UNDER FLUOROSCOPY AND THE TIP WAS OBSERVED TO BE BALLED UP LIKE YARN AT THE END OF THE SHEATH. THE PHYSICIAN INSERTED A CATHETER (MANUFACTURER UNSPECIFIED) IN ATTEMPT TO UNRAVEL THE WIRE GUIDE; HOWEVER, THE BALLED UP TIP SHEARED OFF. THE CATHETER WAS USED TO PUSH BROKEN TIP INTO THE PROFUNDA SO THAT IT WOULD NOT MIGRATE. THE PHYSICIAN THEN ATTEMPTED RETRIEVAL OF THE TIP WITH A SNARE (MANUFACTURER UNSPECIFIED). THE TIP WAS ABLE TO BE SNARED, BUT BECAME HOOKED UNDER THE PATIENT'S SKIN DURING REMOVAL, AND REMAINED WITHIN THE PATIENT'S ANATOMY. FURTHER RETRIEVAL HAS NOT BEEN SCHEDULED AT THIS TIME; IT IS UNKNOWN AS TO WHETHER RETRIEVAL WILL BE RE-ATTEMPTED. ACCESS WAS GAINED VIA THE PATIENT'S RIGHT GROIN. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 7348096 ↗
• InjuryMar 6, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY, THE APPROACH HYDRO ST MICROWIRE WIRE GUIDE WAS IN THE DORSALIS PEDIS, WHICH WAS HIGHLY CALCIFIED. WHEN THE PHYSICIAN ATTEMPTED TO PULL BACK ON THE WIRE, THE DISTAL PORTION SEPARATED AND REMAINED WITHIN THE PATIENT'S VESSEL. AFTER THE PHYSICIAN CONSULTED WITH VASCULAR SURGERY, THE FACILITY DECIDED TO LEAVE THE REMAINING WIRE PORTION INDEFINITELY. THE PHYSICIAN STATED THAT THE WIRE LIKELY SEPARATED DUE TO THE CALCIFICATION. 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.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7317470 ↗
• MalfunctionDec 5, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PERIPHERAL ANGIOGRAM, WHILE PASSING THE APPROACH HYDRO ST MICROWIRE WIRE GUIDE PAST A LESION IN THE TIBIAL ARTERY, THE WIRE TIP BROKE OFF INSIDE OF THE PATIENT. THE BROKEN TIP REMAINED IN THE CXI CATHETER BEING UTILIZED; BOTH WERE ABLE TO BE EASILY REMOVED AS A UNIT. 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 7083452 ↗
• InjuryDec 5, 2016Material Separation; Material Separation

  THE HYDROPHILIC COATING ON THE WIRE WAS SHEARED OFF INTO AN ARTERY IN THE DIGIT OF THE PATIENTS FOOT. THEY ATTEMPTED TO REMOVE THE EMBOLIZED PIECE OF WIRE USING AN ASPIRATION CATHETER. THE PIECE WAS NOT REMOVED AND THE PHYSICIANS DETERMINED THAT IT WAS SAFEST TO LEAVE THE FOREIGN BODY IN THE PATIENT SO THAT IT WOULD NOT DAMAGE ANY HEALTHY VESSELS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6144645 ↗