SYNCHRO 2 M00326110Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04546540688736), received between Oct 3, 2018 and Aug 22, 2025 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (7 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-0226-2020 · Root cause: Employee error · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A CEREBRAL INTERVENTIONAL PROCEDURE; A PORTION OF THE SUBJECT GUIDEWIRE WAS DETACHED AND WAS NOT ABLE TO BE RETRIEVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22877882 ↗
• InjuryFeb 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE FRACTURED WHILE BEING USED TO TREAT A PATIENT WITH AN ABDOMINAL AORTIC ENDOGRAFT ANEURYSM LEAK. THE SUBJECT GUIDEWIRE FRACTURED INSIDE THE PATIENT IN A LOCATION THAT WAS TO BE COIL EMBOLIZED AND IT WAS NOT RETRIEVED. THE UNFRACTURED PORTION OF THE WIRE WAS REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16368359 ↗
• MalfunctionJun 28, 2022Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING OF THE SUBJECT GUIDEWIRE WAS PEELED OFF. 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 14843718 ↗
• MalfunctionOct 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE THE SUBJECT GUIDEWIRE FELL APART FROM THE TIP IN AN INTRACRANIAL ARTERY. IT WAS TAKEN AWAY SUCCESSFULLY. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12629469 ↗
• InjurySep 27, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN A-COM CEREBRAL ANEURYSM COIL EMBOLIZATION PROCEDURE, PHYSICIAN INSERTED THE CATHETER INTO THE ANEURYSM USING THE JAILED BALLOON TECHNIQUE AND EMBOLIZATION WAS PERFORMED AFTER PLACING A STENT. HE TRIED TO CHANGE THE POSITION OF THE CATHETER USING THE SUBJECT GUIDEWIRE AND TRIED TO RE-INSERT THE CATHETER INTO THE ANEURYSM USING TRANS CELL TECHNIQUE. WHEN THE SUBJECT GUIDEWIRE WAS REMOVED IT WAS SEEN THAT THE COATING WAS PEELED OFF. IT WASN¿T CONFIRMED IF THE PEELING WAS OF THE CATHETER OR THE SUBJECT GUIDEWIRE. THERE MIGHT BE SOME COATING FRAGMENTS LEFT INSIDE THE PATIENTS ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12531199 ↗
• InjuryJan 7, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE OF THROMBECTOMY, GUIDEWIRE (SUBJECT DEVICE) BROKE OFF WHILE ADVANCEMENT OF THE GUIDEWIRE INTO THE ICA (INTERNAL CAROTID ARTERY). THE OPERATOR PULLED OUT ENTIRE BROKEN PART OF TIP OF THE GUIDEWIRE WITH A TREVO DEVICE. THE TIP WAS REMOVED AND THEN PHYSICIAN PROCEEDED WITH THE THROMBECTOMY.

  Patient problems: No Information

  MAUDE report 11135031 ↗
• MalfunctionDec 21, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING CEREBRAL ANEURYSM EMBOLIZATION PROCEDURE, WHILE PREPARATION OF CATHETER WITH GUIDEWIRE, OPERATOR FELT RESISTANCE AND GUIDEWIRE (SUBJECT DEVICE) DID NOT PASS THROUGH THE CATHETER EVEN WITH THE ENTIRE PURGING PROCESS. THE DOCTOR COMMENTED THAT THE GUIDEWIRE DID NOT HAVE THE HYDROPHILIC COATING. THE DOCTOR REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11048133 ↗
• MalfunctionOct 30, 2020Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE GUIDEWIRE WAS BROKEN, AND THE PTFE (POLYTETRAFLUOROETHYLENE) COATING WAS PEELED OFF. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10760428 ↗
• MalfunctionAug 18, 2020Device Difficult to Setup or Prepare; Stretched; Device Difficult to Setup or Prepare; Stretched

  THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED AND RECEIVED ON (B)(6) 2020 FOR ANALYSIS AND WAS EXAMINED. BASED ON THE ANALYSIS OF THE DEVICE, THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS BROKEN/FRACTURED AND EXTENSIVELY STRETCHED DURING THE PROCEDURE. THE PATIENTS MEDICAL CONDITION WAS GOOD. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. BASED IN THE ANALYSIS OF THE DEVICE, THE NEW UPDATED AWARENESS DATE IS (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10423571 ↗
• MalfunctionMay 24, 2019Peeled/Delaminated; Peeled/Delaminated

  BASED ON THE INVESTIGATION OF THE RETURNED PRODUCT, THE GUIDEWIRE (SUBJECT DEVICE) WAS FOUND TO HAVE THE POLYTETRAFLUOROETHYLENE (PTFE) COATING PEELING. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8642441 ↗
• MalfunctionMar 8, 2019Break; Break

  IT WAS REPORTED THAT SUDDENLY DURING THE PROCEDURE, THE OPERATOR WAS UNABLE TO TORQUE THE GUIDEWIRE. AFTER PULLING BACK THE GUIDEWIRE, THE DISTAL SEGMENT WAS FOUND TO BE BROKEN AND WAS RETRIEVED IN THE MICROCATHETER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8406154 ↗
• InjuryJan 11, 2019Break; Break

  IT WAS REPORTED THAT DURING A TRANSARTERIAL INTRACRANIAL THROMBECTOMY OF THE LEFT MCA (MIDDLE CEREBRAL ARTERY), THE PHYSICIAN WAS ATTEMPTING TO ACCESS THE THROMBUS VIA THE LEFT CAROTID ARTERY AND THE GUIDEWIRE (SUBJECT DEVICE) WAS SHEARED WITHIN THE MICROCATHETER. THE BROKEN GUIDEWIRE WAS IN THE BEND OF THE ASPIRATION CATHETER IN THE CAROTID ARTERY AND A CAROTID CUTDOWN WAS PERFORMED TO REMOVE THE GUIDEWIRE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8242347 ↗
• MalfunctionNov 28, 2018Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE GUIDEWIRE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS SCRAPED OFF ON SEVERAL PLACES ALONG ITS PROXIMAL END. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8113800 ↗
• MalfunctionOct 3, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED DURING PREPARATION, SMALL PIECES OF COATING FROM THE GUIDEWIRE WERE NOTICED AFTER BACKLOADING INTO AN INSERTER. ANOTHER GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7931873 ↗

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-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-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-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-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-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-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-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-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
• 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-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-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