Boston Scientific Corp 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 a Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 a
Brand
Boston Scientific Corp
Lot Codes / Batch Numbers
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
Products Sold
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.
Boston Scientific Corp is recalling Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600, M00456610, M004566 due to The marker band may detach from the sheath and a clinical failure could result in an embolism.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The marker band may detach from the sheath and a clinical failure could result in an embolism.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026