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U.S. Department of Health and Human Services

Class 2 Device Recall Convoy Soft Tip Sheath Multipurpose Introducing Sheath Kits

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 Class 2 Recall
Convoy Soft Tip Sheath Multipurpose Introducing Sheath Kits
see related information
Date Posted April 09, 2009
Recall Status1 Terminated on April 06, 2010
Recall Number Z-1072-2009
Recall Event ID 50771
Premarket Notification
510(K) Numbers
K013866  K022067  K034061  K072719 
Product Classification Introducer, Catheter - Product Code DYB
Product Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600, M00456610, M00456620, M00456630, M00456650, M00456700, M00456710 and M00456760. Manufactured by Thomas Medical Products, Inc. Product is intended for use to facilitate the percutaneous introduction of various types of cardiovascular catheters into either the right or left side of the heart. The sheath may be exchanged and used for left sided placement, after transseptal puncture has first been obtained by another sheath.
Code Information Batch Numbers: 5660, 5662, 5665, 5671, 5661, 5663, 5670 and 5676 and Batch Numbers: S17665, S2053, S1827, S2283,S2382,S20023, S2100, S1917,S2314,S2200,S21439, S2144,S1956,S2315,S2002,S22763, S2240, S2027,S2390,S2305,S2382, S2276,S2053,S2520,S23827,S17392, S2305,S2077,S2559,S1701,S18274, S2386,S2100,S2588,S1701,S19033, S2542,S2121,S2637,S2421,S19561, S1734,S2240,S1918,S20021, S1746, S2280, S2305, S1823 1 S2016 8 S2221 8 S2310 6 S2582 7 S1823 2 S2029 6 S2223 0 S2310 7 S2589 0 S1827 6 S2037 0 S2223 1 S2310 8 S2600 7 S1847 2 S2043 7 S2223 2 S2342 8 S2613 9 S1864 9 S2043 8 S2229 5 S2346 4 S2615 7 S1869 6 S2043 9 S2229 6 S2346 5 S2615 8 S1870 9 S2044 0 S2229 7 S2360 6 S2621 5 S1874 9 S2049 5 S2248 5 S2360 7 S2632 8 S1884 4 S2071 5 S2250 5 S2369 9 S2632 9 S1888 4 S2071 6 S2250 8 S2371 7 S2635 9 S1892 1 S2082 1 S2274 1 S2405 8 S2641 5 S1895 8 S2099 6 S2274 2 S2413 0 S2648 1 S1899 2 S2099 7 S2277 5 S2413 1 S1899 3 S2100 5 S2277 6 S2447 3 S1899 4 S2102 0 S2279 4 S2478 4 S1899 5 S2102 1 S2282 6 and S2493 3.
Recalling Firm/
Manufacturer
Boston Scientific Corp
150 Baytech Dr
San Jose, California 95134-2302
Manufacturer Reason
for Recall
The marker band may detach from the sheath and a clinical failure could result in an embolism.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action The firm initiated the recall on December 24, 2009 and notified consignees via "Urgent Company Initiated Medical Device Recall - Immediate Action Required" letters which explain the reason for the recall and request the affected product be returned to the Boston Scientific Corporation Distribution Center. An amendment letter with two additional Convoy Advanced Delivery Sheath Kit models (M0045748ST0 and M0045749ST0) was sent to affected customers on January 27, 2009. Direct questions about this recall to your local Sales Representative.
Quantity in Commerce 31,340 of all units
Distribution Worldwide Distribution.
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 = DYB and Original Applicant = BOSTON SCIENTIFIC
510(K)s with Product Code = DYB and Original Applicant = BOSTON SCIENTIFIC CORP.
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