SYNCHRO 2 M00326420Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04546540688774), received between Sep 18, 2017 and Mar 6, 2026 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 reports).

2 FDA recall records name this device's identifier, 1 still open.

12 other recalls cover devices cleared under the same FDA submission (K053268); 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.

Recalls naming this device

1. Apr 18, 2024Open, Classified

   Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.

   Z-1941-2024 · Root cause: Component design/selection · FDA record ↗

2. Jun 8, 2018Terminated

   The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

   Z-0230-2020 · Root cause: Employee error · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Fracture

  THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS OBSERVED THAT THE DISTAL TIP OF SUBJECT GUIDEWIRE WAS FRACTURED DURING USE. ALSO, THE MID SECTION OF THE SUBJECT GUIDEWIRE WAS NOTED TO BE KINKED/BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539086 ↗
• MalfunctionJul 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE WAS USED DURING THROMBECTOMY PROCEDURE WHEN THE SUBJECT GUIDEWIRE WAS NAVIGATED TO THE DESIRED LOCATION (M2 REGION), THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS BROKEN OFF IN THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE BOTH FRACTURED PIECES OF THE SUBJECT GUIDEWIRE (DISTAL AND PROXIMAL PART) FROM THE PATIENT. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED WITH ANOTHER GUIDEWIRE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495866 ↗
• MalfunctionDec 10, 2024Fracture; Fracture

  ANALYSIS OF THE RETURNED SUBJECT GUIDEWIRE DEVICE REVEALED THAT THE DISTAL END OF THE SUBJECT GUIDEWIRE WAS NOTED TO BE BROKEN/FRACTURED AT 193CM FROM THE PROXIMAL END DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20889990 ↗
• MalfunctionApr 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A HEPATIC ARTERIAL MAPPING CASE, DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS FRACTURED DURING USE AND VASOSPASM WAS OBSERVED DUE TO THIS EVENT. THE FRACTURED PIECE OF GUIDEWIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. THE PATIENT CONDITION IS DETAILED AS FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vasoconstriction

  MAUDE report 19032210 ↗
• InjuryApr 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE URETERAL PROCEDURE, THE GUIDEWIRE (SUBJECT DEVICE) FRACTURED DURING USE AND THE PATIENT HAD TO UNDERGO ASPIRATION FOR THE REMOVAL OF THE BROKEN WIRE AND THE KIDNEY STONES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663086 ↗
• InjuryApr 25, 2022Fracture; Fracture

  IT WAS REPORTED DURING AN EMBOLIZATION PROCEDURE THE SUBJECT GUIDEWIRE MET RESISTANCE WHEN ADVANCED IN THE CATHETER. IT WAS FOUND WHEN FLUOROSCOPIC VERIFICATION WAS PERFORMED, THE SUBJECT GUIDEWIRE WAS FRACTURED AT THE DISTAL SECTION. THE PHYSICIAN TRIED FORWARD THE MICROCATHETER AND ATTEMPTED TO RETRIEVE THE GUIDEWIRE FRAGMENT, BUT WHEN RETRACTED BACK THE MICRO IT DID NOT WORK AND THE FRAGMENT REMAINED IN THE PATIENTS VASCULATURE. THIS RESULTED IN A SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE GUIDEWIRE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14193963 ↗
• MalfunctionJul 9, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COATING OF THE GUIDEWIRE (SUBJECT DEVICE) CAME OFF WHEN INSERTING INTO THE INTRODUCER SHEATH. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12145665 ↗
• MalfunctionJul 7, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING PROCEDURE THE COATING CAME OFF THROUGH THE INTRODUCER, DR. WHIPPED OFF AND CONTINUED USING IT. THEREFORE, THIS MIGHT CAUSED VESSEL THROMBOSIS. PATIENT CURRENTLY STATUS IS UNKNOWN.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 12128992 ↗
• MalfunctionMay 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE STROKE PROCEDURE, A GUIDEWIRE (SUBJECT DEVICE) WAS ADVANCED TO M2 WITHOUT ANY DIFFICULTIES. AFTER ACCESSING M2 SECTION, A PART OF THE DISTAL TIP OF THE SUBJECT GUIDEWIRE SHEARED OFF. A CATHETER WHICH WAS ALREADY IN USE WAS USED WITH SUCTION TO RETRIEVE FRACTURED TIP OF THE SUBJECT GUIDEWIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795729 ↗
• InjuryFeb 16, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) BROKE OFF INSIDE THE PATIENT'S ANATOMY AND IT GOT STUCK IN THE DISSECTION. THE PHYSICIAN WAS NOT ABLE TO FIND THE TRUE LUMEN OF THE SUBJECT GUIDEWIRE. NO FURTHER INFORMATION ABOUT PATIENT'S CLINICAL AND HEALTH CONSEQUENCES IS AVAILABLE AT THE MOMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11334217 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT GUIDE WIRE GOT STUCK INSIDE THE MICRO CATHETER. WHEN WITHDRAWN FROM PATIENT¿S ANATOMY IT LOOKED LIKE THE OUTER PART WAS BROKEN AND INNER PART WAS RIPPED. THE PHYSICIAN REPLACED WITH NEW DEVICES AND PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10705600 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT GUIDE WIRE PERFORATED THE M2 BLOOD VESSEL. THE PATIENT'S CONDITION, ADVERSE CONSEQUENCES AND MEDICAL INTERVENTION DONE DUE TO THE REPORTED EVENT ARE NOT KNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A PREVIOUSLY PLACED FLOW DIVERTER. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Perforation

  MAUDE report 10245991 ↗
• MalfunctionNov 2, 2018Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THE PTFE (POLYTETRAFLUOROETHYLENE) COATING WAS PEELED. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8034189 ↗
• MalfunctionAug 28, 2018Break; Break

  DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REPORTED THAT THE GUIDEWIRE DISTAL TIP WAS SEPARATED. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7824385 ↗
• MalfunctionAug 17, 2018Break; Break

  IT WAS REPORTED THAT THE DISTAL TIP OF THE GUIDEWIRE DETACHED DURING REMOVAL FROM THE DISPENSER HOOP. THE PHYSICIAN REPLACED IT WITH A NEW GUIDEWIRE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7793892 ↗
• InjuryAug 14, 2018Break; Break

  IT WAS REPORTED THAT THE GUIDEWIRE WAS BROKEN OFF DURING MANIPULATION OF THE WIRE. A SNARE WAS USED TO REMOVE THE BROKEN WIRE FROM THE PATIENT'S BODY AND A NEW GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7783658 ↗
• MalfunctionMay 3, 2018Break; Break

  IT WAS REPORTED THAT THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS BROKEN DURING THE PROCEDURE. THE BROKEN PART WAS REMOVED WITH THE MICROCATHETER AS ONE UNIT WITH NO CLINICAL CONSEQUENCE TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW GUIDEWIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7484062 ↗
• MalfunctionSep 18, 2017Break; Break

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE GUIDEWIRE DISTAL TIP WAS DETACHED. THERE WERE NO REPORTED PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6874105 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K053268. One submission often covers many models, so check the product and lot details in each record.

• Z-0874-2011 · Jun 7, 2010 · Terminated
  Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distribute
• Z-0869-2011 · Jun 7, 2010 · Terminated
  Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Soft Pre Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is dis
• Z-0871-2011 · Jun 7, 2010 · Terminated
  Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft Pre Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is dis
• Z-0868-2011 · Jun 7, 2010 · Terminated
  Boston Scientific brand Synchro 2 Guidewire, 0.14" 200 cm Soft. Boston Scientific; Made in: 2405 West Orton Circle, West Valley City, UT 84119 The Synchro guidewire series is int
• Z-0875-2011 · Jun 7, 2010 · Terminated
  Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard Pre-Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is
• Z-0870-2011 · Jun 7, 2010 · Terminated
  Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by
• Z-0872-2011 · Jun 7, 2010 · Terminated
  Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distribute
• Z-0873-2011 · Jun 7, 2010 · Terminated
  Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard Pre-Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is
• Z-2068-2010 · Jun 3, 2010 · Terminated
  Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 200 cm x 10 cm, REF 50-810, UPN M001508100 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Ori
• Z-2069-2010 · Jun 3, 2010 · Terminated
  Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 200 cm x 10 cm, REF 50-811, UPN M001508110 Sterilized with ethylene oxide gas, Rx Only, Made
• Z-2071-2010 · Jun 3, 2010 · Terminated
  Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 300 cm x 10 cm, REF 50-815, UPN M001508150 Sterilized with ethylene oxide gas, Rx Only, Made
• Z-2070-2010 · Jun 3, 2010 · Terminated
  Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 300 cm x 10 cm, REF 50-814, UPN M001508140 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Ori