Approach G50791Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002507913), received between Mar 7, 2016 and Sep 14, 2021 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 reports).

2 FDA recall records name this device's identifier, 2 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. Mar 5, 2026Open, Classified

   Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

   Z-1776-2026 · Root cause: Incorrect or no expiration date · FDA record ↗

2. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2021Unraveled Material; Unraveled Material

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12469400 ↗
• InjuryMar 19, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529266 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Sepsis

  MAUDE report 8598105 ↗
• MalfunctionMar 28, 2019Stretched; Stretched

  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 8459758 ↗
• MalfunctionMar 25, 2019Stretched; Stretched

  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 8448404 ↗
• MalfunctionAug 11, 2017Sticking; Sticking

  IT WAS REPORTED THAT DURING A LOWER LEG ANGIOGRAM, AN APPROACH CTO MICROWIRE WIRE GUIDE BECAME STUCK IN THE CATHETER WHEN REMOVING. THE SAME PROBLEM WAS REPORTED WITH TWO OTHER WIRE GUIDES. EACH DEVICE IS BEING REPORTED AND DOCUMENTED IN THE FOLLOWING REPORT NUMBERS: 1820334-2017-02072, 1820334-2017-02073, AND 1820334-2017-02114. 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 Known Impact Or Consequence To Patient

  MAUDE report 6789153 ↗
• MalfunctionJul 24, 2017Sticking; Sticking

  IT WAS REPORTED THAT DURING A LOWER LEG ANGIOGRAM, AN APPROACH CTO MICROWIRE WIRE GUIDE BECAME STUCK IN THE CATHETER WHEN REMOVING. THE SAME PROBLEM WAS REPORTED WITH TWO OTHER WIRE GUIDES. EACH DEVICE IS BEING REPORTED AND DOCUMENTED IN THE FOLLOWING REPORT NUMBERS: 1820334-2017-02073, 1820334-2017-02114, AND 1820334-2017-02115. 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 Known Impact Or Consequence To Patient

  MAUDE report 6737702 ↗
• MalfunctionJun 13, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A PTA PROCEDURE ON A (B)(6) YEAR OLD MALE PATIENT, THEY WERE UNABLE TO REMOVE THE APPROACH CTO MICROWIRE WIRE GUIDE FROM ANOTHER MANUFACTURER'S CATHETER. THE PATIENT'S ANATOMY WAS VERY CALCIFIED AND THE APPROACH CTO MICROWIRE WIRE GUIDE WAS INSERTED WITH SOME FRICTION INITIALLY. WHEN THEY ATTEMPTED TO REMOVE THE WIRE, IT WAS FIXED IN ANOTHER MANUFACTURER'S CATHETER. AS A RESULT, THEY REMOVED THE SUPPORT CATHETER WITH THE WIRE AND COMPLETED THE CASE. AFTER THE PROCEDURE, THEY ATTEMPTED TO PUSH THE WIRE OUT OF THE OTHER MANUFACTURER'S CATHETER BACKWARDS BUT THEY WERE UNSUCCESSFUL. THEY WERE ONLY ABLE TO PUSH THE WIRE FORWARD. DUE TO THE AMOUNT OF CALCIFICATION, THE PATIENT WAS TAKEN TO SURGERY. 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 6638609 ↗
• MalfunctionMay 11, 2017Uncoiled; Uncoiled

  DURING A LOWER LEG PERIPHERAL ANGIOGRAM, THE TIP OF THE APPROACH CTO MICROWIRE WIRE GUIDE UNCOILED (1820334-2017-00946). THE PHYSICIAN OPENED A SECOND APPROACH CTO MICROWIRE WIRE GUIDE AND IT PROCEEDED TO UNCOIL AS WELL (1820334-2017-00947). THE PHYSICIAN USED A COMPETITOR'S WIRE TO FINISH 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 Known Impact Or Consequence To Patient

  MAUDE report 6561699 ↗
• MalfunctionMay 11, 2017Uncoiled; Uncoiled

  DURING A LOWER LEG PERIPHERAL ANGIOGRAM, THE TIP OF THE APPROACH CTO MICROWIRE WIRE GUIDE UNCOILED (1820334-2017-00946). THE PHYSICIAN OPENED A SECOND APPROACH CTO MICROWIRE WIRE GUIDE AND IT PROCEEDED TO UNCOIL AS WELL (1820334-2017-00947). THE PHYSICIAN USED A COMPETITOR'S WIRE TO FINISH 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 Known Impact Or Consequence To Patient

  MAUDE report 6561553 ↗
• MalfunctionApr 6, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LEFT LOWER EXTREMITY ANGIOGRAM, USING AN APPROACH CTO MICROWAVE WIRE GUIDE, WITHIN TWO MINUTES OF ATTEMPTING TO PASS THE CTO, THE TIP OF TWO APPROACH CTO MICROWIRE GUIDES SEPARATED. THE TIP OF THE WIRES WERE STILL ATTACHED AND ABLE TO BE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A COMPETITOR'S WIRE. THERE WAS NOTHING LEFT BEHIND AND NO HARM TO THE PATIENT. THIS MEDWATCH IS FOR DEVICE LOT #7611876, PLEASE SEE MEDWATCH WITH G9# 1820334-2017-00553 FOR DEVICE LOT #7638094.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6463361 ↗
• MalfunctionApr 5, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LEFT LOWER EXTREMITY ANGIOGRAM, USING AN APPROACH CTO MICROWAVE WIRE GUIDE, WITHIN TWO MINUTES OF ATTEMPTING TO PASS THE CTO, THE TIP OF TWO APPROACH CTO MICROWIRE GUIDES SEPARATED. THE TIP OF THE WIRES WERE STILL ATTACHED AND ABLE TO BE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A COMPETITOR'S WIRE. THERE WAS NOTHING LEFT BEHIND AND NO HARM TO THE PATIENT. THIS MEDWATCH IS FOR DEVICE LOT #7638094, PLEASE SEE MEDWATCH WITH MFR REPORT# 1820334-2017-00556 FOR DEVICE LOT #7611876.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6461749 ↗
• MalfunctionMar 10, 2017Material Separation; Material Separation

  IT WAS REPORTED, DURING LEFT LEG LOWER EXTREMITY ANGIOGRAM, THE COILING OF THE TIP SEPARATED FROM THE APPROACH CTO MICROWIRE WIRE GUIDE. IT WAS STILL CONNECTED TO WIRE. PER ADDITIONAL INFORMATION, THERE WAS RESISTANCE ENCOUNTERED DURING THE REMOVAL. AS THE WIRE BEING REMOVED THROUGH A CXI CATHETER. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6396590 ↗
• MalfunctionJan 13, 2017Material Separation; Material Separation

  IT WAS REPORTED THE TIP OF THE DEVICE SEPARATED. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE DEVICE SEPARATION OCCURRED OUTSIDE OF THE PATIENTS BODY THEREFORE A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6249219 ↗
• MalfunctionMar 7, 2016Material Separation; Material Separation

  THE PHYSICIAN WAS USING THE WIRE WITH A ANOTHER MANUFACTURER'S DEVICE AND CXI SUPPORT CATHETER. UPON ATTEMPTING TO CROSS CTO, THE PHYSICIAN NOTED THE WIRE HAD BROKEN OFF. UPON REMOVING THE DEVICES USED, ALL DEVICES AND DEVICE PORTIONS CAME OUT OF THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT铠BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5483026 ↗