SYNCHRO 2 M00326310Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540688743), received between Jun 29, 2021 and Jan 24, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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

   Z-0227-2020 · Root cause: Employee error · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING STENOSIS CASE, WHEN THE PHYSICIAN USED THE SUBJECT GUIDEWIRE TO SUPER SELECT THE VESSEL, UNDER DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) THE PHYSICIAN FOUND DISTAL OF THE SUBJECT GUIDEWIRE FRACTURED AT C3 SEGMENT. THE PHYSICIAN THEN USED MIDDLE CATHETER AND BALLOON AS A MEDICAL INTERVENTION TO TAKE THE FRACTURED SUBJECT GUIDEWIRE OUT. IT TOOK THE PHYSICIAN ABOUT 2 HOURS TO TAKE THE FRACTURED SUBJECT GUIDEWIRE OUT. THE CURRENT CONDITION OF THE PATIENT IS STABLE. 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 18576227 ↗
• MalfunctionNov 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING ANEURYSM EMBOLIZATION CASE THE PROXIMAL OF THE PARENT VESSEL WAS VERY TORTUOUS. THE OPERATOR USED THE GUIDEWIRE AND THE MICROCATHETER TO GO INTO THE PARENT VESSEL BUT THEY COULD NOT BE DELIVERED. THE OPERATOR WITHDREW THE GUIDEWIRE AND FOUND THAT IT WAS KINKED. THUS, THE OPERATOR REPLACED IT WITH THE SUBJECT GUIDEWIRE. DURING DELIVERY OF THE SUBJECT GUIDEWIRE THE OPERATOR FOUND ITS TIP WAS ABNORMAL. ON WITHDRAWAL, TIP OF THE SUBJECT GUIDEWIRE WAS FRACTURED INSIDE THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND 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 18098461 ↗
• MalfunctionMay 26, 2023Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE GUIDEWIRE (SUBJECT DEVICE) DISTAL TIP WAS BROKEN/FRACTURED DURING USE DURING THE PROCEDURE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011383 ↗
• InjuryFeb 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE STROKE TREATMENT WHEN PHYSICIAN DELIVERED THE BALLOON AFTER CROSSING THE TIGHT STENOSIS, THE TIP OF THE SUBJECT GUIDEWIRE WAS FRACTURED INSIDE THE PATIENT'S ANATOMY. ATTEMPTS WERE MADE TO RETRIEVE THE BROKEN TIP BUT THE PHYSICIAN WAS UNSUCCESSFUL AND WAS LEFT INSIDE THE PATIENT. 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 13579319 ↗
• InjuryJun 29, 2021Fracture; Peeled/Delaminated; Fracture; Peeled/Delaminated

  IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE WAS USED ON THE RIGHT LOWER EXTREMITY ARTERIOGRAM AND LYSIS PROCEDURE AND IT WAS NOTICED THAT THE FOREIGN BODY COMPOSED OF SHEARED SUBJECT GUIDEWIRE COATING IN THE TP (TIBIAL PERONEAL) TRUNK ¿ FLOW LIMITING BUT NOT FLOW OBSTRUCTING. ATTEMPTS WERE MADE WITH AN ASPIRATION PUMP, HAND ASPIRATION, AND MULTIPLE DIFFERENT SIZED SNARES TO REMOVE FOREIGN BODY ¿ THOSE ATTEMPTS WERE UNSUCCESSFUL. LYSIS CATHETER PLACEMENT AND INITIATION. CATHETER IS ACROSS THE FOREIGN BODY IN THE TP TRUNK EXTENDING FROM SFA TO DISTAL PTA (POSTERIOR TIBIAL ARTERY). THE SUBJECT GUIDEWIRE BROKE BUT THE PHYSICIAN WAS UNSURE IF ANY SUBJECT GUIDEWIRE WAS LEFT IN THE PATIENT. FOLLOW-UP PROCEDURE ON THE NEXT DAY, THE PHYSICIAN CHOSE TO USE A RETRIEVER DEVICE AND SUCCESSFULLY RETRIEVED THE FOREIGN BODY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12085515 ↗

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-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-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-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-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-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-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-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-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-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-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