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U.S. Department of Health and Human Services

Class 2 Device Recall iSLEEVE" Introducer Set

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 Class 2 Device Recall iSLEEVE" Introducer Setsee related information
Date Initiated by FirmFebruary 20, 2024
Date PostedMarch 28, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1390-2024
Recall Event ID 94041
510(K)NumberK180785 K191871 K230051 K233503 
Product Classification Introducer, catheter - Product Code DYB
ProductBoston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Code Information 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
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information ContactRebecca KinKead Rubio
763-494-1133
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process control
ActionBoston 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.
Quantity in Commerce4060 devices
DistributionWorldwide distribution - US Nationwide and the countries of Canada.
Total Product Life CycleTPLC Device Report
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DYB
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