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U.S. Department of Health and Human Services

Class 2 Device Recall Wiseguide Guide Catheter

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 Class 2 Recall
Wiseguide Guide Catheter
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Date Posted June 18, 2009
Recall Status1 Open
Recall Number Z-1470-2009
Recall Event ID 51865
Premarket Notification
510(K) Numbers
K970823  K974684  K981788 
Product Classification Catheter, Percutaneous - Product Code DQY
Product Boston Scientific Wiseguide Guide Catheter, Sterilized. Wiseguide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced.
Code Information Model Numbers: 8F WG FR3.5, 8F WG FR4, 8F WG FR5, 8F WG FR6, 8F WG FL3, 8F WG FL3.5, 8F WG FL4, 8F WG FL4.5, 8F WG FL5, 8F WG FL6, 8F WG AL1.5 ST, 8F WG AL2 ST, 8F WG AL.75 ST, 8F WG AL1 ST SH, 8F WG AL2 ST SH, 8F WG AL.75 ST SH, 8F WG RC3.5 SC SH, 8F WG IM 110cm, 8F WG AL.75 SH, 8F WG AL4 SH, 8F WG RCB SH, 8F WG IM SH, 8F WG FL3.5 ST SH, 8F WG FL4 ST SH, 8F WG FL4.5 ST SH, 8F WG FL5 ST SH, 8F WG MP1 SH, 8F WG MP HS SH, 8F WG FL4P, 8F WG AR1, 8F WG AR2, 8F WG AL1, 8F WG AL2, 8F WG AL3, 8F WG AL.75, 8F WG AL4, 8F WG VR2, 8F WG RCB, 8F WG VL4 HT, 8F WG VR2 SH, 8F WG LCB, 8F WG VL3 HT SH, 8F WG IM, 8F WG FCL3.5 SH, 8F WG FCL4 SH, 8F WG FCL3.5, 8F WG FCL4, 8F WG FCR4 SH, 8F WG FCR3.5, 8F WG FCR4, 8F WG FL3.5 ST, 8F WG FL4 ST, 8F WG Q3.5, 8F WG Q4, 8F WG Q4.5, 8F WG Q3.5 SH, 8F WG Q4 SH, 8F WG Q4.5 SH, 8F WG FL4.5 ST, 8F WG FL5 ST, 8F WG FR4 90cm, 8F WG MP1, 8F WG RCB 90cm, 8F WG MP2, 8F WG MP HS, 8F WG FR3, 8F WG FR3 SH, 8F WG IM 90cm, 8F WG IM 90cm SH, 8F WG RC4 SC, 8F WG RC4 SC SH, 8F WG RC3.5 SC, 8F WG FR3.5 SH, 8F WG FR4 SH, 8F WG FR5 SH, 8F WG ART3, 8F WG ART3 SH, 8F WG ART3.5, 8F WG ART3.5 SH, 8F WG ART4, 8F WG FR6 SH, 8F WG ART4 SH, 8F WG FL3 SH, 8F WG FR4.5, 8F WG FR4.5 SH, 8F WG FL3.5 SH, 8F WG FL4 SH, 8F WG FL4.5 SH, 8F WG FL5 SH, 8F WG FL6 SH, 8F WG FL4A SH, 8F WG CLS3, 8F WG CLS3.5, 8F WG CLS4, 8F WG CLS4.5, 8F WG CLS3 SH, 8F WG CLS3.5 SH, 8F WG CLS4 SH, 8F WG CLS4.5 SH, 8F WG IMC 90cm, 8F WG AR1 SH, 8F WG AR2 SH, 8F WG AL1 SH, 8F WG AL2 SH, 8F WG AL3 SH, 8F WG VL3, 8F WG VL3.5, 8F WG VL4, 8F WG VL4.5, 8F WG VL3 SH, 8F WG VL3.5 SH, 8F WG VL4 SH, 8F WG VL4.5 SH, 8F WG VL5 SH, 8F WG VL6 SH, 8F WG AL1.5, 8F WG AL1.5 SH, 8F WG FR3.5 ST, 8F WG FR4 ST, 8F WG FR3.5 ST SH, 8F WG FR4 ST SH, 7F WISEGUIDE FR3.5, 7F WISEGUIDE FR4, 7F WISEGUIDE FR5, 7F WISEGUIDE FR6, 7F WISEGUIDE FL3, 7F WISEGUIDE FL3.5, 7F WISEGUIDE FL4, 7F WISEGUIDE FL4.5, 7F WISEGUIDE FL5, 7F WISEGUIDE FL6, 7F WISEGUIDE AL1 ST, 7F WISEGUIDE AL.75 ST, 7F WISEGUIDE AL1 ST SH, 7F WISEGUIDE AL.75 ST SH, 7F WISEGUIDE RC3.5 SC SH, 7F WISEGUIDE IM 85cm, 7F WISEGUIDE IM 110cm, 7F WISEGUIDE AL.75 SH, 7F WISEGUIDE AL4 SH, 7F WISEGUIDE RCB SH, 7F WISEGUIDE LCB SH, 7F WISEGUIDE IM SH, 7F WISEGUIDE MP EL G SH, 7F WISEGUIDE FL3.5 ST SH, 7F WISEGUIDE FL4 ST SH, 7F WISEGUIDE FL4.5 ST SH, 7F WISEGUIDE FL5 ST SH, 7F WISEGUIDE MP1 SH, 7F WISEGUIDE MP2 SH, 7F WISEGUIDE MP HS SH, 7F WISEGUIDE AR1, 7F WISEGUIDE AR2, 7F WISEGUIDE AL1, 7F WISEGUIDE AL2, 7F WISEGUIDE AL3, 7F WISEGUIDE AL.75, 7F WISEGUIDE AL4, 7F WISEGUIDE VL2.5, 7F WISEGUIDE RCB, 7F WISEGUIDE VL3 HT, 7F WISEGUIDE LCB, 7F WISEGUIDE IM, 7F WISEGUIDE FCL3.5 SH, 7F WISEGUIDE FCL4 SH, 7F WISEGUIDE MP EL G, 7F WISEGUIDE FCL4.5 SH, 7F WISEGUIDE FCL3.5, 7F WISEGUIDE FCL4, 7F WISEGUIDE FCL5, 7F WISEGUIDE FCR5 SH, 7F WISEGUIDE FL3.5 ST, 7F WISEGUIDE FCR4, 7F WISEGUIDE FCR5, 7F WISEGUIDE FL4 ST, 7F WISEGUIDE Q3.5, 7F WISEGUIDE Q4, 7F WISEGUIDE Q4.5, 7F WISEGUIDE Q5, 7F WISEGUIDE Q3.5 SH, 7F WISEGUIDE Q4 SH, 7F WISEGUIDE Q4.5 SH, 7F WISEGUIDE FL4.5 ST, 7F WISEGUIDE FL5 ST, 7F WISEGUIDE MP1, 7F WISEGUIDE MP2, 7F WISEGUIDE MP HS, 7F WISEGUIDE FR3, 7F WISEGUIDE FR3 SH, 7F WISEGUIDE IM 90cm, 7F WISEGUIDE IM 90cm SH, 7F WISEGUIDE RC4 SC, 7F WISEGUIDE RC4 SC SH, 7F WISEGUIDE RC3.5 SC, 7F WISEGUIDE FR3.5 SH, 7F WISEGUIDE FR4 SH, 7F WISEGUIDE FR5 SH, 7F WISEGUIDE ART3, 7F WISEGUIDE ART3 SH, 7F WISEGUIDE ART3.5, 7F WISEGUIDE ART3.5 SH, 7F WISEGUIDE FR6 SH, 7F WISEGUIDE ART4, 7F WISEGUIDE ART4 SH, 7F WISEGUIDE ART4.5, 7F WISEGUIDE ART4.5 SH, WISEGUIDE FL3 SH, 7F WISEGUIDE FR4.5, 7F WISEGUIDE FR4.5 SH, 7F WISEGUIDE FL3.5 SH, 7F WISEGUIDE FL4 SH, 7F WISEGUIDE FL5 SH, 7F WISEGUIDE FL6 SH, 7F WISEGUIDE CLS3, 7F WISEGUIDE CLS3.5, 7F WISEGUIDE CLS4, 7F WISEGUIDE CLS4.5, 7F WISEGUIDE CLS3 SH, 7F WISEGUIDE CLS3.5 SH, 7F WISEGUIDE IMC 90cm, 7F WISEGUIDE AR1 SH, 7F WISEGUIDE AR2 SH, 7F WISEGUIDE AL1 SH, 7F WISEGUIDE AL2 SH, 7F WISEGUIDE AL3 SH, 7F WISEGUIDE VL3, 7F WISEGUIDE VL3.5, 7F WISEGUIDE VL4, 7F WISEGUIDE VL4.5, 7F WISEGUIDE VL5, 7F WISEGUIDE VL6, 7F WISEGUIDE VL3 SH, 7F WISEGUIDE VL3.5 SH, 7F WISEGUIDE VL4 SH, 7F WISEGUIDE AL1.5, 7F WISEGUIDE AL1.5 SH, 7F WISEGUIDE FR3.5 ST, 7F WISEGUIDE FR4 ST, 7F WISEGUIDE FR4 ST SH, 6F WISEGUIDE FR3.5, 6F WISEGUIDE FR4, 6F WISEGUIDE FR5, 6F WISEGUIDE FR6, 6F WISEGUIDE FL3, 6F WISEGUIDE FL3.5, 6F WISEGUIDE FL4, 6F WISEGUIDE FL4.5, 6F WISEGUIDE FL5, 6F WISEGUIDE FL6, 6F WISEGUIDE IM 85cm, 6F WISEGUIDE RCB SH, 6F WISEGUIDE LCB SH, 6F WISEGUIDE IM SH, 6F WISEGUIDE MP1 SH, 6F WISEGUIDE MP HS SH, 6F WISEGUIDE AR1, 6F WISEGUIDE AR2, 6F WISEGUIDE AL1, 6F WISEGUIDE AL2, 6F WISEGUIDE AL3, 6F WISEGUIDE AL.75, 6F WISEGUIDE AL4, 6F WISEGUIDE VR1, 6F WISEGUIDE VR2, 6F WISEGUIDE RCB, 6F WISEGUIDE VL3.5 HT, 6F WISEGUIDE VL4 HT, 6F WISEGUIDE LCB 6F WISEGUIDE IM, 6F WISEGUIDE FCL3.5, 6F WISEGUIDE FCL4, 6F WISEGUIDE FCL4.5, 6F WISEGUIDE FCR3.5, 6F WISEGUIDE FL4 ST, 6F WISEGUIDE Q3.5, 6F WISEGUIDE Q4, 6F WISEGUIDE Q4.5, 6F WISEGUIDE Q5, 6F WISEGUIDE Q3.5 SH, 6F WISEGUIDE Q4 SH, 6F WISEGUIDE FL4.5 ST, 6F WISEGUIDE FL5 ST, 6F WISEGUIDE MP1, 6F WISEGUIDE MP2, 6F WISEGUIDE MP HS, 6F WISEGUIDE FR3, 6F WISEGUIDE IM 90cm, 6F WISEGUIDE FR3.5 SH, 6F WISEGUIDE Radial ST, 6F WISEGUIDE Radial, 6F WISEGUIDE FR4 SH, 6F WISEGUIDE ART3, 6F WISEGUIDE ART3 SH, 6F WISEGUIDE ART3.5, 6F WISEGUIDE ART3.5 SH, 6F WISEGUIDE ART4, 6F WISEGUIDE ART4 SH, 6F WISEGUIDE ART4.5, 6F WISEGUIDE FL3.5 SH, 6F WISEGUIDE FL4 SH, 6F WISEGUIDE ML4, 6F WISEGUIDE Radial FX, 6F WISEGUIDE CLS3, 6F WISEGUIDE CLS3.5, 6F WISEGUIDE CLS4, 6F WISEGUIDE CLS4.5, 6F WISEGUIDE CLS3.5 SH, 6F WISEGUIDE KIMNY, 6F WISEGUIDE KIMNY FX, 6F WISEGUIDE KIMNY SH, 6F WISEGUIDE IMC 90cm, 6F WISEGUIDE AR1 SH, 6F WISEGUIDE AR2 SH, 6F WISEGUIDE AL1 SH, 6F WISEGUIDE AL2 SH, 6F WISEGUIDE VL3, 6F WISEGUIDE VL3.5, 6F WISEGUIDE VL4, 6F WISEGUIDE VL4.5, 6F WISEGUIDE VL5, 6F WISEGUIDE VL6, 6F WISEGUIDE VL3.5 SH, 6F WISEGUIDE VL4 SH, 6F WISEGUIDE AL1.5, 6F WISEGUIDE FR3.5 ST and 6F WISEGUIDE FR4 ST. Lot Numbers: 20106283, 20113656, 20120985, 20122073, 20123899, 20126049, 20128131, 20130186, 20131732, 20134681, 20139339, 20106284, 20108193, 20111663, 20113657, 20115952, 20119538, 20120962, 20123862, 20126025, 20130151, 20131716, 20136120, 20137555, 20139326, 20140535, 20119595, 20110123, 20111374, 20115980, 20103073, 20134682, 20137582, 20141541, 20103074, 20104480, 20106285, 20113658, 20119578, 20120977, 20122047, 20123877, 20127208, 20128112, 20130164, 20131726, 20134672, 20137572, 20140546, 20101258, 20106286, 20108513, 20113659, 20119534, 20120958, 20122030, 20123859, 20126023, 20127181, 20128098, 20130148, 20131713, 20133539, 20134662, 20136118, 20137551, 20139323, 20140532, 20103075, 20123900, 20137583, 20103076, 20106287, 20116001, 20123897, 20139338, 20103077, 20106288, 20106289, 20108194, 20111664, 20110143, 20127239, 20136132, 20110140, 20110144, 20116006, 20130185, 20139340, 20113660, 20116895, 20119605, 20123901, 20139341, 20106290, 20128132, 20134683, 20123902, 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20123882, 20127212, 20111704, 20113685, 20119587, 20122053, 20123883, 20127213, 20128116, 20130169, 20133556, 20134673, 20110119, 20139349, 20120992, 20113686, 20102685, 20104496, 20122089, 20122090, 20141551, 20122091, 20120993, 20122092, 20130199, 20120994, 20110129, 20111375, 20122093, 20103132, 20105609, 20111706, 20113687, 20110095, 20113688, 20120995, 20139350, 20101268, 20119584, 20136129, 20103133, 20127250, 20128141, 20130200, 20133570, 20136146, 20123910, 20110115, 20101269, 20104499, 20111707, 20115977, 20101270, 20103134, 20110106, 20103135, 20104500, 20106182, 20113689, 20119592, 20122056, 20123887, 20128119, 20104501, 20115951, 20123889, 20126653, 20127222, 20108521, 20122094, 20127251, 20101271, 20104502, 20113690, 20119548, 20126028, 20127189, 20137557, 20139328, 20141526, 20103138, 20106312, 20111708, 20113691, 20123911, 20127252, 20137595, 20139351, 20103139, 20110120, 20113692, 20127253, 20128142, 20141552, 20103140, 20113693, 20123912, 20113694, 20139352, 20141553, 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Recalling Firm/
Manufacturer
Boston Scientific Corporation
1 Scimed Pl
Maple Grove, Minnesota 55311-1565
Manufacturer Reason
for Recall
Boston Scientific has initiated a recall of the Wiseguide Guide Catheter. They have received reports of difficulties in connecting the product hubs with the Y-Adaptors and toughy borst connectors. If there is difficulty making such connection, there is a potential for prolongation or delay of the procedure in order to exchange the catheter or connector. There have been 41 complaints in the US as
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Consignees were sent a "Boston Scientific Urgent Medical Device Recall" letter dated March 11, 2009. The letter was addressed to Risk Manager/Field Action Contacts describing the problem including instructions for affected device handling and a request to return the enclosed Reply Verification Tracking Form. Further questions can be addressed to Boston Scientific at 763-494-1634.
Quantity in Commerce U.S. and U.S. territories: 22,728; OUS: 11,308
Distribution Worldwide Distribution -- USA, United Arab Emirates, Dutch Antilles, Argentina, Austria, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Egypt, Spain, Finland, France, Great Britain, India, Indonesia, Ireland, Iraq, Italy, Jamaica, Japan, Kuwait, Sri Lanka, Libya, Netherlands, Norway, Poland, Puerto Rico, Qatar, Saudi Arabia, Sweden, Singapore, Syria, Turkey and South Africa.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = SCIMED LIFE SYSTEMS, INC.
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