Boston Scientific Corporation
414 recalls on record · Latest: Feb 11, 2026
FDA Devices Critical Feb 11, 2026
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
FDA Devices Critical Feb 11, 2026
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
FDA Devices Critical Feb 11, 2026
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
FDA Devices Critical Feb 11, 2026
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
FDA Devices Critical Oct 22, 2025
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Devices Critical Oct 22, 2025
Model Number S702, ALTRUA 2 DR SL Pacemaker
FDA Devices Critical Oct 22, 2025
Model Number U128, VALITUDE CRT-P EL MRI
FDA Devices Critical Oct 22, 2025
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Devices Moderate Oct 22, 2025
TENACIO Pump without InhibiZone; UPN: 72404420;
FDA Devices Critical Oct 22, 2025
Model Number L101, ESSENTIO DR SL Pacemaker
FDA Devices Critical Oct 22, 2025
Model Number L209 PROPONENT DR (VDD) SL Pacemaker
FDA Devices Critical Oct 22, 2025
Model Number U226, VISIONIST CRT-P EL
FDA Devices Moderate Oct 22, 2025
TENACIO Pump with InhibiZone; UPN: 72404429;
FDA Devices Critical Oct 22, 2025
PROPONENT SR SL (Model L200)
FDA Devices Critical Oct 22, 2025
Model Number U228, VISIONIST CRT-P EL MRI
FDA Devices Moderate Oct 22, 2025
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
FDA Devices Critical Oct 22, 2025
Model Number L221 PROPONENT DR EL Pacemaker
FDA Devices Critical Oct 22, 2025
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Devices Critical Oct 22, 2025
ACCOLADE DR EL MRI (Model L331)
FDA Devices Critical Oct 22, 2025
Model Number L121 ESSENTIO DR EL Pacemaker
FDA Devices Critical Oct 22, 2025
Model Number L110, ESSENTIO SR SL MRI Pacemaker
FDA Devices Moderate Oct 1, 2025
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
FDA Devices Moderate Sep 17, 2025
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
FDA Devices Moderate Sep 17, 2025
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
FDA Devices Moderate Sep 17, 2025
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
FDA Devices Moderate Sep 17, 2025
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240…
FDA Devices Moderate Sep 17, 2025
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. …
FDA Devices Critical Sep 10, 2025
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left …
FDA Devices Critical Sep 10, 2025
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WA…
FDA Devices Critical Sep 10, 2025
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left …
FDA Devices Critical Sep 10, 2025
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATC…
FDA Devices Critical Sep 10, 2025
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left…
FDA Devices Critical Sep 10, 2025
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATC…
FDA Devices Critical Aug 27, 2025
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, …
FDA Devices Critical Aug 27, 2025
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658…
FDA Devices Moderate Aug 20, 2025
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
FDA Devices Moderate Jul 16, 2025
Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the pe…
FDA Devices Moderate Jul 16, 2025
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VX…
FDA Devices Moderate Jul 16, 2025
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized…
FDA Devices Moderate Jul 16, 2025
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J …
FDA Devices Moderate May 7, 2025
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Fr…
FDA Devices Moderate May 7, 2025
IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Free…
FDA Devices Moderate May 7, 2025
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Fre…
FDA Devices Moderate Feb 5, 2025
AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
FDA Devices Moderate Feb 5, 2025
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
FDA Devices Moderate Feb 5, 2025
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
FDA Devices Moderate Feb 5, 2025
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
FDA Devices Moderate Feb 5, 2025
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
FDA Devices Moderate Feb 5, 2025
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
FDA Devices Moderate Feb 5, 2025