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Pvs 2000 SYNCHRO2 Guidewire

by Boston Scientific - Precision Vascular 510(k)

Active United States

510(k) K053268

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK053268 Date13 Mar 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

13 recalls · 1 ongoing · FDA

    • Ongoing Z-1941-2024 FDA Class II initiated 18 Apr 2024

    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.

  • 8 recalls, same reason

    • Terminated Z-0868-2011 FDA Unclassified (pre-2012) initiated 7 Jun 2010
    • Terminated Z-0870-2011 FDA Unclassified (pre-2012) initiated 7 Jun 2010
    • Terminated Z-0873-2011 FDA Unclassified (pre-2012) initiated 7 Jun 2010
    • Terminated Z-0871-2011 FDA Unclassified (pre-2012) initiated 7 Jun 2010
    • Terminated Z-0875-2011 FDA Unclassified (pre-2012) initiated 7 Jun 2010
    • Terminated Z-0869-2011 FDA Unclassified (pre-2012) initiated 7 Jun 2010
    • Terminated Z-0872-2011 FDA Unclassified (pre-2012) initiated 7 Jun 2010
    • Terminated Z-0874-2011 FDA Unclassified (pre-2012) initiated 7 Jun 2010

    The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system.

  • 4 recalls, same reason

    • Terminated Z-2070-2010 FDA Unclassified (pre-2012) initiated 3 Jun 2010
    • Terminated Z-2071-2010 FDA Unclassified (pre-2012) initiated 3 Jun 2010
    • Terminated Z-2068-2010 FDA Unclassified (pre-2012) initiated 3 Jun 2010
    • Terminated Z-2069-2010 FDA Unclassified (pre-2012) initiated 3 Jun 2010

    Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is coated with polytetrafluoroethylene (PTFE). Through internal inspection process, the firm determined that Fathom guidewires from affected lots may exhibit a P

Specification

510(k)

510(k) Number
FDA Product Code
DQX
Device Class
Class II
Regulation
21 CFR Part 870.1330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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