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Class 2 Device Recall Boston Scientific Synchro 2 Guidewire |
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| Date Initiated by Firm |
June 07, 2010 |
| Date Posted |
January 07, 2011 |
| Recall Status1 |
Terminated 3 on January 10, 2011 |
| Recall Number |
Z-0872-2011 |
| Recall Event ID |
56388 |
| 510(K)Number |
K053268
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| Product Classification |
Wire, guide, catheter - Product Code DQX
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| Product |
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 |
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 |
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
47900 Bayside Pkwy
Fremont CA 94538-6515
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| For Additional Information Contact |
Deborah Springer
800-845-4598
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Manufacturer Reason
for Recall |
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.
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FDA Determined
Cause 2 |
Other |
| Action |
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 Bob.Ware@bsci.com 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. |
| Quantity in Commerce |
36,049 total units, all sizes |
| 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. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database |
510(K)s with Product Code = DQX and Original Applicant = BOSTON SCIENTIFIC - PRECISION VASCULAR
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