Class 1 Device Recall Boston Scientific ENROUTE

• Date Initiated by Firm: July 09, 2026
• Date Posted: August 20, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2977-2026
• Recall Event ID: 99454
• 510(K)Number: K153485
• Product Classification: Temporary Carotid Catheter for Embolic Capture - Product Code NTE
• Product: Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
• Code Information: GTIN 00811311020829, Lot Numbers: 200832, 200850, 201057, 201070, 201087, 201113, 201128, 201143, 201157, 201177, 201190, 201220, 201235, 201312, 201333, 201351, 201379, 201407, 201422, 201487, 300015, 300028, 300043, 300058, 300075, 300099, 300114, 300135, 300143, 300154, 300168, 300188, 300203, 300213, 300229, 300252, 300262, 300271, 300311, 300325, 300346, 300358, 300377, 300395, 300404, 300418, 300430, 300445, 300471, 300492, 300520, 300532, 300545, 300559, 300566, 300581, 300600, 300613, 300630, 300664, 300679, 300680, 300690, 300697, 300751, 300775, 300781, 300782, 300800, 300802, 300818, 300844, 300861, 300867, 300874, 300879, 300898, 300904, 300917, 300925, 300932, 300944, 300952, 300977, 300989, 301005, 301007, 301022, 301036, 301051, 301077, 301091, 301115, 301136, 301184, 301229, 301232, 301234, 301235, 301276, 301277, 301278, 301290, 301328, 301336, 301355, 301376, 301385, 301400, 301418, 301435, 301443, 301457, 301464, 301476, 301487, 301535, 301550, 301565, 301596, 301626, 301636, 301644, 301660, 301722, 301739, 301750, 301761, 301771, 301779, 301792, 301811, 301831, 301844, 301871, 301880, 301901, 301923, 301935, 301945, 301958, 301975, 301991, 302016, 302033, 302049, 302058, 302115, 302135, 302154, 302162, 302166, 302176, 302182, 302187, 302200, 302221, 302234, 302250, 302267, 302298, 302310, 302326, 302337, 302340, 302353, 302366, 302376, 302394, 302403, 302423, 302459, 302471, 302484, 302494, 302500, 302510, 302527, 302540, 302550, 302568, 302585, 302596, 302621, 302648, 302657, 302668, 302676, 302688, 302714, 302726, 302728, 302737, 302749, 302758, 302766, 302785, 302789, 302807, 302832, 302845, 302862, 302868, 302895, 302917, 302918, 302926, 302944, 303020, 303027, 303035, 303047, 303052, 303063, 303082, 303088, 303100, 303119, 303129, 303130, 303147, 303154, 303160, 304001, 304038, 304044, 304128, 304129, 304142, 304147, 304203, 304215, 304237, 304251, 304261, 304276, 304285, 304300, 304323, 304327, 304336, 304344, 305002, 305004, 305036, 305051, 305065, 305082, 305084, 305117, 305135, 305141, 305143, 305160, 305180, 305194, 305230, 305247, 305258, 305269, 305275, 305286, 305313, 305340, 305344, 305366, 305396, 305404, 305432, 305449, 305470, 305484, 305522, 305548, 305571, 305573, 305592, 305611, 305632, 305639, 305673, 305693, 305711, 305719, 305735, 305756, 305799, 305808, 305826, 305835, 305849, 305873, 305885, 305892, 305949, 305967, 305979, 305987, 306009, 306017, 306034, 306045, 306071, 306077, 306116, 306117, 306126, 306129, 306134, 306141, 306146, 306156, 306260, 306697, 306715, 306726, 304051-2, 304056-2, 304057- 2, 304058-2, 304154-2, 304168-2, 304169-2, 304182-2, 304186-2, 304190-2, 304259-2.
• FEI Number: 3002095335
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Scimed Pl; Maple Grove MN 55311-1565
• For Additional Information Contact: Clara Johnson; 763-494-1133
• Manufacturer Reason for Recall: Potential for arterial sheath tip separation or partial tip separation during use.
• FDA Determined Cause: Under Investigation by firm
• Action: Boston Scientific issued an "Urgent Medical Device Removal" notice to its consignees on 7/9/2026 via FedEx. The notice explained the issue, potential risk, and requested the following actions to be taken: 1. Immediately discontinue use and segregate Affected Product. 2. Complete and return the Reply Verification Tracking Form (RVTF) to get a Return Goods Authorization (RGA) number. " Indicate the quantity of SINGLE units you will be returning for credit " If you have product that is listed and not included on your RVTF, provide the material number, lot number, and quantity you intend to return on your RVTF and return via: Email: BSCFieldActionCenter@bsci.com or Fax: BSC Field Action Center 1-763-415-7708. This Removal Notice must be completed and returned even if you do not have any Affected Product. 3. Once Boston Scientific receives your completed RVTF, you will be contacted and given an RGA number for product return. Package and ship affected product: " Write the RGA number in large print on the enclosed (red/white) return address label " Affix the return address label to the outside of box " Use our Federal Express account number: 9205-2515-6 to return package via second-day delivery "Seal box and return to: Boston Scientific Corporation, US Distribution, Center, 500 Commander Shea Blvd, Quincy, MA 02171 Credit will be issued for all returned Affected Product. 5. If you have sent a response to this Removal Notice to anyone other than Boston Scientific, we would not have received your response. Please ensure response is sent to email or fax indicated above. Forward this notice to relevant personnel and any facilities to which the product was transferred. 6. Continue to follow the standard of practice. If you require additional information regarding this recall, please contact your local Boston Scientific representative or the Sr. Quality Manager at 793.494.1133.
• Quantity in Commerce: 115,458 units
• Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica
• 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 = NTE