Class 2 Device Recall iSLEEVE" Introducer Set

• Date Initiated by Firm: February 20, 2024
• Date Posted: March 28, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1390-2024
• Recall Event ID: 94041
• 510(K)Number: K180785 K191871 K230051 K233503
• Product Classification: Introducer, catheter - Product Code DYB
• Product: Boston 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 Contact: Rebecca 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: Process control
• Action: 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.
• Quantity in Commerce: 4060 devices
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = DYB and Original Applicant = Boston Scientific Corporation