Boston Scientific Corporation: 296 recalls on record

Recalls filed with 1 agency: FDA (296).

First recall on record: June 27, 2012. Most recent: September 23, 2026.

Risk classification: Class I: 73 · Class II: 221 · Class III: 2

Most recent recalls

DateAgencyProduct
December 4, 2019FDABoston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536…Z-0554-2020
December 4, 2019FDABoston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620Z-0549-2020
September 25, 2019FDASubcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S…Z-2542-2019
May 29, 2019FDAAURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL …Z-1399-2019
May 29, 2019FDAAURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 40…Z-1396-2019
January 16, 2019FDAIntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablati…Z-0701-2019
May 16, 2018FDACapio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general s…Z-1619-2018
May 16, 2018FDACapio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applicatio…Z-1617-2018
March 28, 2018FDAPercutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Maleco…Z-1104-2018
March 14, 2018FDAAuriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used…Z-0898-2018
January 24, 2018FDAPROPONENT SR PacemakerZ-0373-2018
January 24, 2018FDAVISIONIST CRT-P PacemakerZ-0365-2018
January 24, 2018FDAACCOLADE DR PacemakerZ-0355-2018
November 15, 2017FDAVIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrilla…Z-0079-2018
November 15, 2017FDARESONATE X4 CRT-D, Model G447, Sterile.Z-0081-2018
November 15, 2017FDARESONATE EL ICD VR, Model D432, Sterile.Z-0077-2018
November 15, 2017FDAMOMENTUM X4 CRT-D, Model G138, Sterile.Z-0080-2018
November 15, 2017FDARESONATE EL ICD DR, Model D433, Sterile.Z-0078-2018
September 20, 2017FDAFFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to con…Z-3132-2017
August 23, 2017FDAEMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. …Z-3038-2017
August 23, 2017FDASQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provi…Z-3039-2017
July 12, 2017FDABoston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M0054…Z-2674-2017
July 12, 2017FDABoston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast medi…Z-2645-2017
May 10, 2017FDAThe JETSTREAM is a rotational atherectomy catheter system designed for use in debulking a…Z-1922-2017
April 19, 2017FDABoston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN)…Z-1781-2017

Questions about this company

How many recalls does Boston Scientific Corporation have?
Recalert has 296 U.S. recalls on record for Boston Scientific Corporation, published between June 27, 2012 and September 23, 2026.
Which agencies have handled Boston Scientific Corporation recalls?
Boston Scientific Corporation appears as the recalling firm in recalls from: FDA (296).

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