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Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm… recallZ-0872-2011 · Boston Scientific Corporation · initiated Jun 7, 2010

Terminated All recalls posted in January 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Other

What the company is doing

Boston Scientific Corporation sent an Urgent Medical Device Recall letter dated June 7, 2010, by Federal Express to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use of and segregate the affected product. Complete and return the Reply Verification Tracking Form even if they did not have any affected product. Contact the Customer Service Call Center to obtain a Returned Goods Authorization (RGA) Number at (800) 811-3211, Option #1. E-mail or Fax the completed and signed Reply Verification Tracking Form to email [email protected] or the Field Action Fax (510) 624-2475. PackageShip and return the affected product along with the original Reply Verification Tracking Form by Federal Express to: Boston Scientific Corporation US Distribution Center Boston Scientific Marina Bay Customer Fulfillment Center 500 Commander Shea Blvd. Quincy, Massachusetts 02171 RGA: ____________ For questions regarding this recall call (510) 624-2563.

Recall details

Recall number
Z-0872-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 7, 2010
Posted by the FDA
Jan 7, 2011
Recalling firm
Boston Scientific Corporation
Quantity
36,049 total units, all sizes
Product code
DQX
FDA submissions
K053268
Distribution
Worldwide Distribution - USA including CA, CO, IN, MD, MI, OR, TX, and VA and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Great Britian, Greece, Honduras, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Switzerland, Thailand, Tunisia, Turkey, and Ukraine.

Product description

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 distributed by Boston Scientific Corporation, Fremont, CA The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Material # M00326410: lot/use by dates: B17096 7/31/2011  B17097 7/31/2011  B17098 7/31/2011  B17099 7/31/2011  B17185 7/31/2011  B17186 7/31/2011  B17187 7/31/2011  B17188 7/31/2011  B17198 7/31/2011  B17199 7/31/2011  B17287 7/31/2011  B17288 7/31/2011  B17327 8/31/2011  B17328 8/31/2011  B17329 8/31/2011  B17330 8/31/2011  B17331 8/31/2011  B17390 8/31/2011  B17391 8/31/2011  B17392 8/31/2011  B17393 8/31/2011  B17394 8/31/2011  B17469 8/31/2011  B17470 8/31/2011  B17472 8/31/2011  B17473 8/31/2011  B17474 8/31/2011  B17504 8/31/2011  B17507 8/31/2011  B17508 8/31/2011  B17509 8/31/2011  B17510 8/31/2011  B17602 9/30/2011  B17664 9/30/2011  B17665 9/30/2011  B17714 9/30/2011  B17715 9/30/2011  B17716 9/30/2011  B17717 9/30/2011  B17718 9/30/2011  B17719 9/30/2011  B17825 10/31/2011  B17826 10/31/2011  B817851 9/30/2011  B17931 10/31/2011  B17932 10/31/2011  B17933 10/31/2011  B17934 10/31/2011  B17984 10/31/2011  B17985 10/31/2011  B17986 10/31/2011  B17987 10/31/2011  B18003 10/31/2011  B18004 10/31/2011  B18082 10/31/2011  B18198 11/30/2011  B18200 11/30/2011  B18201 11/30/2011  B18202 11/30/2011  B18259 11/30/2011 B18260 11/30/2011  B18261 11/30/2011  B18266 11/30/2011  B18267 11/30/2011  B18268 11/30/2011  B18315 11/30/2011  B18316 11/30/2011  B18317 11/30/2011  B18318 11/30/2011  B18319 11/30/2011  B18394 12/31/2011  B18444 12/31/2011  B18445 12/31/2011  B18446 12/31/2011  B18447 12/31/2011  B18448 12/31/2011  B18449 12/31/2011  B18479 12/31/2011  B18480 12/31/2011  B18481 12/31/2011  B18484 12/31/2011  B18535 12/31/2011  B18536 12/31/2011  B18537 12/31/2011  B18538 12/31/2011  B18701 12/31/2011  B18742 1/31/2012  B18743 1/31/2012  B18812 1/31/2012  B18813 1/31/2012  B18814 1/31/2012  B18815 1/31/2012  B18816 1/31/2012  B18841 1/31/2012  B18842 1/31/2012  B18934 1/31/2012  B18987 2/29/2012  B18988 2/29/2012  B19023 2/29/2012  B19024 2/29/2012  B19110 2/29/2012  B19120 2/29/2012  B19187 3/31/2012  B19346 3/31/2012  B19379 3/31/2012  819384 3/31/2012

Other devices under the same FDA submission

8 devices cleared under K053268 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 56388).

Sources and updates

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