Boston Scientific Corporation Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
GTIN 08714729950660, Batch Numbers: 31368041, 31390084, 31390088, 31390089, 31501866, 31501867, 31501868, 31501869, 31520897, 31520898, 31604492, 31616143, 31633635, 31650457, 31664216, 31664217, 31671140, 31671143, 31693638, 31693639, 31724952, 31732930, 31732931, 31740806, 31740807, 31740808, 31751118, 31777134, 31786582, 31786583, 31818290, 31818299, 31818341, 31818342, 31818343, 31818344, 31818345, 31818346, 31818347, 31838684, 31838685, 31838686, 31838687, 31838688, 31838689, 31877302, 31877304, 31877305, 31877306, 31904748, 31904749, 31923755, 31923756, 31953345, 31953348, 32008170, 32031191, 32031192, 32031193, 32031196, 32059171, 32059386, 32059387, 32059388, 32059392, 32059393, 32059394, 32059396, 32059397, 32212151, 32212153, 32230544, 32230545, 32230546, 32230547, 32230548, 32230549, 32230550, 32230551, 32284196, 32284198, 32284200, 32304326, 32304327, 32304328, 32313757, 32313758, 32313759, 32322405, 32322406, 32322407, 32331162, 32331163, 32331164, 32331165, 32427040, 32452794, 32461848, 32461849, 32461850, 32470848, 32470849, 32480089, 32480090, 32481344, 32481345, 32522178, 32530450, 32530451, 32602892, 32602893, 32611557, 32611558, 32611559, 32620708, 32620709, 32620710, 32629426, 32642560, 32642561
Products Sold
GTIN 08714729950660, Batch Numbers: 31368041, 31390084, 31390088, 31390089, 31501866, 31501867, 31501868, 31501869, 31520897, 31520898, 31604492, 31616143, 31633635, 31650457, 31664216, 31664217, 31671140, 31671143, 31693638, 31693639, 31724952, 31732930, 31732931, 31740806, 31740807, 31740808, 31751118, 31777134, 31786582, 31786583, 31818290, 31818299, 31818341, 31818342, 31818343, 31818344, 31818345, 31818346, 31818347, 31838684, 31838685, 31838686, 31838687, 31838688, 31838689, 31877302, 31877304, 31877305, 31877306, 31904748, 31904749, 31923755, 31923756, 31953345, 31953348, 32008170, 32031191, 32031192, 32031193, 32031196, 32059171, 32059386, 32059387, 32059388, 32059392, 32059393, 32059394, 32059396, 32059397, 32212151, 32212153, 32230544, 32230545, 32230546, 32230547, 32230548, 32230549, 32230550, 32230551, 32284196, 32284198, 32284200, 32304326, 32304327, 32304328, 32313757, 32313758, 32313759, 32322405, 32322406, 32322407, 32331162, 32331163, 32331164, 32331165, 32427040, 32452794, 32461848, 32461849, 32461850, 32470848, 32470849, 32480089, 32480090, 32481344, 32481345, 32522178, 32530450, 32530451, 32602892, 32602893, 32611557, 32611558, 32611559, 32620708, 32620709, 32620710, 32629426, 32642560, 32642561
Boston Scientific Corporation is recalling Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to due to Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemos. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
Recommended Action
Per FDA guidance
Boston Scientific issued an Urgent Field Safety Notice - Medical Device Product Removal to its consignees on 02/20/2027 via FedEx. The notice explained the problem with the device, potential risk, and requested the following: 1. Immediately discontinue use and segregate the affected product. 2. Complete and return the RVTF to get a Return Goods Authorization (RGA) number. 3. Once Boston Scientific receives your completed RVTF, you will be contacted within 2 business days and provided an RGA number for product return. For questions, contact your local Boston Scientific 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