SYNCHRO 2 M00326520Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540688798), received between Dec 9, 2022 and Dec 9, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

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-0232-2020 · Root cause: Employee error · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE MECHANICAL THROMBECTOMY PROCEDURE, THE SUBJECT GUIDEWIRE WAS BROKEN INTO 2 FRAGMENTS. MEDICAL INTERVENTION WAS PERFORMED TO EXTRACT THE BROKEN FRAGMENT BUT WAS UNSUCCESSFUL AND LEFT INSIDE THE PATIENT ANATOMY. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15954243 ↗

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-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-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-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-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-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-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-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-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-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