Motion Hybrid Wire Guide MHW-035150Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002448469), received between Jul 22, 2019 and Apr 22, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

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 18, 2026.

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.

• MalfunctionApr 22, 2026Insufficient Device Problem Information

  IT WAS REPORTED "DATE OF EVENT: 27JAN2026 CUSTOMER: ST (B)(6) [UNITED STATES] BLUE COATING SCRAPED OFF AND ENDED UP INTO THE PATIENT'S URETHRA. UNKNOWN IF THE DEVICE WAS RETRIEVED OR NOT. IMAGE OF COMPLAINT DEVICE SUPPLIED SEPARATELY."

  Patient problems: Insufficient Information

  MAUDE report 24957988 ↗
• MalfunctionApr 19, 2026Insufficient Device Problem Information

  IT WAS REPORTED "DATE OF EVENT: 07OCT2025 CUSTOMER: (B)(6) [UNITED STATES] I [COOK SALES REP] RECEIVED A CALL FROM # C21448-85 THAT YESTERDAY DURING A CASE A SURGEON FIRED THE LASER AND LEFT BEHIND A PIECE OF THE OUTER COATING FROM THE MOTION WIRE (IT MIGHT HAVE INSTEAD BEEN A PIECE OF THE HYDROPHILIC TIP, THEY ARE NOT SURE). CUSTOMER ASKED IF IT WAS OKAY TO LEAVE THE PIECE BEHIND INSIDE THE PATIENT, AND I INFORMED THEM THAT COOK MEDICAL CANNOT APPROVE OF ANY FOREIGN BODIES LEFT BEHIND IN A PATIENT. THAT IS ULTIMATELY UP TO THE SURGEON TO DECIDE. CUSTOMER DID NOT RETAIN PACKAGING OR BROKEN PRODUCT AND PROVIDED NO PICTURES/VIDEO EVIDENCE OF THIS INCIDENT."

  Patient problems: Insufficient Information

  MAUDE report 24921381 ↗
• MalfunctionApr 15, 2026Peeled/Delaminated; Insufficient Device Problem Information

  IT WAS REPORTED: DATE OF EVENT: 25-FEB-2026, CUSTOMER: (B)(6) MEDICAL CTR [UNITED STATES]. COMPLEX URETEROSCOPY CASE AT END OF DAY AT SYB. HAD TWO SEPARATE WIRE ISSUES WEAR COATING CAME OFF DISTANTLY. ONE WAS A GLIDE AND ONE WAS EITHER A MOTION OR SENSOR WIRE. THIS HYBRID WIRE MAY HAVE RESULTED IN FOREIGN BODY (COATING) STUCK INSIDE DISTAL STENT. SEE PHOTOS. "JUST WANTED TO SHOW YOU SOME IMAGES OF SOME WIRES THAT CAME APART DURING A CASE AT SYB. THE RN THERE DID NOT SAVE THE PACKAGING OR THE WIRES." I HAVE NOT RECEIVED ANY INFO ON PATIENT DETAILS NOR ITEM/LOT NUMBERS. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887369 ↗
• MalfunctionDec 2, 2025Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED "GUIDEWIRE BROKE WHILE INSIDE PATIENT WHEN USING LASER. SURGEON REMOVED THE BROKEN PIECES. POTENTIAL ISSUE WITH LASER HITTING GUIDEWIRE CAUSING BREAKAGE. -------------------------------------- WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : LITHOTRIPSY -------------------------------------- WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) ; -------------------------------------- THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696098 ↗
• MalfunctionNov 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED "THE PHYSICIAN WAS USING A LASER TO TREAT THE STONE. AFTER HE REMOVED ALL OF THE STONE, HE WENT TO PUT IN A BLACK SILICONE STENT. WHEN REMOVING WIRE, AFTER PLACING THE STENT, THE WIRE BROKE INTO SEVERAL PIECES IN THE KIDNEY. THE PHYSICIAN REMOVED EVERYTHING AND THEN WENT BACK IN AND RETRIEVED ALL OF THE WIRE FRAGMENTS WITH A BASKET. THE PROCEDURE HAD BEEN SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. ADDITIONAL INFORMATION RECEIVED WHEN DID THE EVENT OCCUR? (PRIOR TO USE, DURING INSERTION, DURING REMOVAL, ETC.) -OBSERVED DURING REMOVAL. PLEASE DESCRIBE THE ACCESS SITE WAS WELL AS THE TARGET LOCATION FOR USE OF THE WIRE. -URETHRA, KIDNEY. DESCRIBE THE PATIENT'S ANATOMY AND DISEASE SEVERITY. (VESSEL, CALCIFICATION, TORTUOSITY, ANGULATION, ETC.)? -URETERAL STRICTURE. WAS THE WIRE ALTERED FROM ITS ORIGINAL CONDITION PRIOR TO USE? -NO. WHAT IS THE PATIENT'S STATUS OR OUTCOME? -FINE. HAVE ANY KINDS OF INTERVENTION, ADDITIONAL PROCEDURES BEEN PERFORMED? -REMOVAL OF DEVICE FRAGMENTS. WHAT PRE-EXISTING CONDITIONS/CO-MORBIDITIES DID THE PATIENT HAVE? -UNKR. WHAT OTHER MEDICAL DEVICES WERE UTILIZED IN THIS CASE? PLEASE PROVIDE THE MANUFACTURER, BRAND, SIZE, AND PART NUMB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550473 ↗
• MalfunctionNov 13, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED "ON THE(B)(6) 2025 THE WIRE STARTED TO SHRED INSIDE THE PATIENT. PIECES OF TEFLON DETACHED INSIDE THE PATIENT AND HAD TO BE RETRIEVED WITH A BASKET. ALL PARTS WERE RETRIEVED. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED: WHEN DID THE EVENT OCCUR? (PRIOR TO USE, DURING INSERTION, DURING REMOVAL, ETC.) -UNKR PLEASE DESCRIBE THE ACCESS SITE WAS WELL AS THE TARGET LOCATION FOR USE OF THE WIRE. -URETHRA, BLADDER. DESCRIBE THE PATIENT'S ANATOMY AND DISEASE SEVERITY. (VESSEL, CALCIFICATION, TORTUOSITY, ANGULATION, ETC.)? -UNKR WAS THE WIRE ALTERED FROM ITS ORIGINAL CONDITION PRIOR TO USE? -UNKR, NO. WHAT IS THE PATIENT'S STATUS OR OUTCOME? -FINE. HAVE ANY KINDS OF INTERVENTION, ADDITIONAL PROCEDURES BEEN PERFORMED? -REMOVAL OF DEVICE FRAGMENTS. WHAT PRE-EXISTING CONDITIONS/CO-MORBIDITIES DID THE PATIENT HAVE? -UNKR. WHAT OTHER MEDICAL DEVICES WERE UTILIZED IN THIS CASE? PLEASE PROVIDE THE MANUFACTURER, BRAND, SIZE, AND PART NUMBER IF POSSIBLE. -UNKR. WAS THE WIRE ALTERED FROM ITS ORIGINAL CONDITION PRIOR TO USE? -UNKR. WAS ANY KINKING OF THE WIRE NOTED? (IF SO, ARE SHARP EDGES PRESENT) -NO. CAN PHOTOS OR VIDEO FROM THE PROCEDURE, (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550458 ↗
• MalfunctionNov 12, 2025Break

  TIP OF A COOK WIRE USED FOR STENT PLACEMENT BROKE OFF INSIDE OF THE PATIENT DURING PROCEDURE. THE SURGEON REMOVED THE TIP OF THE COOK WIRE FROM THE PATIENT, REPORTED THE INCIDENT TO THE COOK INDUSTRY REPRESENTATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531733 ↗
• MalfunctionNov 12, 2025Material Fragmentation

  SURGEON WAS USING A HYBRID WIRE GUIDE WITHIN THE PATIENT URETER AND NOTICE MATERIAL SHEDDING OFF FROM THE WIRE CAUSING IT TO STAY WITHIN THE URETER AND BLADDER. SURGEONDISCONTINUED USE OF WIRE AND REQUEST A DIFFERENT WIRE TO BE USED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23531705 ↗
• MalfunctionOct 27, 2025Material Split, Cut or Torn

  GUIDEWIRE BROKE WHILE INSIDE PATIENT WHEN USING LASER. SURGEON REMOVED THE BROKEN PIECES. POTENTIAL ISSUE WITH LASER HITTING GUIDEWIRE CAUSING BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390185 ↗
• MalfunctionSep 18, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED "A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE MOTION HYBRID WIRE GUIDE, G4484, WAS USED. (B)(6) CALLED TO SHARE A MOTION WIRE (G44846) LOT # 9019157405 HAD STRIPPED COATING LEAVING DEBRIS IN THE BLADDER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23087146 ↗
• MalfunctionSep 18, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED "A PATIENT OF UNDICLOSED GENDER AND AGE UNDEWENT AN UNSPECIFIED PROCEDURE IN WHISH THE MOTION HYBRID WIRE GUIDE, G44846 WAS USED. (B)(6) CENTER (C29022-0) CALLED TO SHARE A MOTION WIRE (G44846) LOT # 9019157405 HAD STRIPPED COATING LEAVING DEBRIS IN THE BLADDER. THE FIRST PHOTOS INCLUDED ARE OF THE PACKAGED AND PHOTOS TAKEN OF THE DEBRIS IN THE BLADDER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086906 ↗
• MalfunctionJul 17, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED: "ON (B)(6) 2025, (B)(6) (UNITED STATES) WAS REMOVED A MOTION HYBRID WIRE GUIDE FROM ACMI SEMI RIGID SCOPE THE COATING SHEARED OFF THE INSIDE OF THE PATIENT WHICH CAUSED A SIGNIFICANT DELAY BECAUSE THE PIECES NEEDED TO BE BASKETED OUT OF THE PATIENT. THE PROCEDURE WAS A URETEROSCOPY WITH LASER LITHOTRIPSY. IT'S UNKNOWN IF ALL THE ALL PIECES OF THE COATING WERE ABLE TO BE REMOVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531872 ↗
• MalfunctionMar 7, 2022Material Separation; Material Separation

  CIRCULATOR WAS INFORMED BY SURGEON THAT "A FRAGMENT OF THE HYDROPHILIC TIP FROM THE MOTION HYBRID WIRE GUIDE BROKE OFF AND WAS RETAINED IN THE PATIENT. " THE SURGEON WAS ABLE TO VISUALIZE THE FRAGMENT WITH THE C-ARM THAT WAS CURRENTLY BEING USED DURING THE OPERATION. CIRCULATOR WAS INFORMED THAT THE FRAGMENT CANNOT BE REMOVED AT THIS TIME. CIRCULATOR NOTIFIED THE CHARGE NURSE AT THE FRONT DESK PER PROTOCOL AND COMPLETED SOS PER PROTOCOL. THE MOTION HYBRID WIRE GUIDE. 035" REF MHW-035150/REF (B)(4), LOT 9007112132, EXPIRATION 01/27/2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 13685001 ↗
• MalfunctionDec 10, 2020Material Separation

  DURING A CYSTOSCOPY, A COOK MOTION HYBRID WIRE GUIDE (MHW-035150; G44846), LOT NUMBER: 9006229355 WAS PLACED IN THE LEFT URETER IN PREPARATION FOR A STENT PLACEMENT. IT WAS NOTED THE BLUE WIRE COATING (NITINOL WITH HYDROPHILIC TIP) CAME OFF WIRE AND WAS IN THE BLADDER. YOU CAN SEE ON THE PICTURE, THE END OF THE WIRE IS MISSING THE BLUE COATING. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10991575 ↗
• InjuryJul 22, 2019Break; Fracture; Break; Fracture

  ON (B)(6) 2019, (B)(6) COMMUNITY HOSPITAL INFORMED (B)(4) (DISTRIBUTOR OF DEVICE) OF AN EVENT INVOLVING A MOTION HYBRID WIRE GUIDE OF UNKNOWN LOT NUMBER. DURING A CYSTOSCOPY AND STENT PLACEMENT PROCEDURE, "WIRE WENT PAST THE IMPACTED STONE BUT THE TIP OF THE WIRE SHEARED OFF. THE TIP IS INSIDE PATIENT; THE TIP OF THE WIRE WILL BE REMOVED IN A WEEK AT THE SAME TIME THE STENT IS REMOVED." A CYSTOSCOPY WITH STENT REMOVAL WAS LATER PERFORMED TO REMOVE THE SEPARATED TIP.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8813380 ↗