Boston Scientific recalls
Boston Scientific appears in 655 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy
FDA Device · Class II · 2015-11-18 · Boston Scientific - RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy
FDA Device · Class I · 2015-11-18 · Boston Scientific - Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU…
FDA Device · Class II · 2015-09-23 · Boston Scientific - Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU2006…
FDA Device · Class II · 2015-09-23 · Boston Scientific - AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide
FDA Device · Class II · 2015-08-19 · Boston Scientific - AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide
FDA Device · Class II · 2015-08-19 · Boston Scientific - AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized
FDA Device · Class II · 2015-08-19 · Boston Scientific - AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide
FDA Device · Class II · 2015-08-19 · Boston Scientific - Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter
FDA Device · Class II · 2015-07-08 · Boston Scientific - CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08
FDA Device · Class II · 2015-06-24 · Boston Scientific - Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Cath…
FDA Device · Class II · 2015-04-08 · Boston Scientific - Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
FDA Device · Class II · 2015-04-08 · Boston Scientific - IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number:…
FDA Device · Class I · 2015-03-11 · Boston Scientific - Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System
FDA Device · Class I · 2015-01-21 · Boston Scientific - Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System
FDA Device · Class I · 2015-01-21 · Boston Scientific - Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System
FDA Device · Class I · 2015-01-21 · Boston Scientific - IntellaMap Orion High Resolution Mapping Catheter
FDA Device · Class II · 2014-12-17 · Boston Scientific - StarMedTec LightTrail¿ Reusable Fibers, 600 um
FDA Device · Class II · 2014-10-15 · Boston Scientific - StarMedTec LightTrail¿ Reusable Fibers, 365 um
FDA Device · Class II · 2014-10-15 · Boston Scientific - StarMedTec LightTrail¿ Reusable Fibers, 800 um
FDA Device · Class II · 2014-10-15 · Boston Scientific - IntellaTip MiFi XP Temperature Ablation Catheter
FDA Device · Class II · 2014-06-25 · Boston Scientific - IntellaTip MiFi XP Temperature Ablation Catheter
FDA Device · Class II · 2014-06-25 · Boston Scientific - IntellaTip MiFi XP Temperature Ablation Catheter
FDA Device · Class II · 2014-06-25 · Boston Scientific - IntellaTip MiFi XP Temperature Ablation Catheter
FDA Device · Class II · 2014-06-25 · Boston Scientific - IntellaTip MiFi XP Temperature Ablation Catheter
FDA Device · Class II · 2014-06-25 · Boston Scientific - IntellaTip MiFi XP Temperature Ablation Catheter
FDA Device · Class II · 2014-06-25 · Boston Scientific - iLab Ultrasound Imaging System
FDA Device · Class II · 2014-04-30 · Boston Scientific - Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664
FDA Device · Class II · 2014-03-19 · Boston Scientific - Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121
FDA Device · Class II · 2014-02-19 · Boston Scientific - Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151
FDA Device · Class II · 2014-02-19 · Boston Scientific - Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R
FDA Device · Class II · 2014-02-05 · Boston Scientific - TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411
FDA Device · Class II · 2014-01-22 · Boston Scientific - Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon C…
FDA Device · Class II · 2014-01-22 · Boston Scientific - TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421
FDA Device · Class II · 2014-01-22 · Boston Scientific - TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for…
FDA Device · Class II · 2014-01-22 · Boston Scientific - TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412
FDA Device · Class II · 2014-01-22 · Boston Scientific - Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
FDA Device · Class II · 2014-01-22 · Boston Scientific - Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140
FDA Device · Class II · 2014-01-22 · Boston Scientific - TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410
FDA Device · Class II · 2014-01-22 · Boston Scientific - TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420
FDA Device · Class II · 2014-01-22 · Boston Scientific - Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile
FDA Device · Class II · 2013-12-11 · Boston Scientific - Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile
FDA Device · Class II · 2013-12-11 · Boston Scientific - Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile
FDA Device · Class II · 2013-12-11 · Boston Scientific - Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated…
FDA Device · Class II · 2013-09-11 · Boston Scientific - Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Mic…
FDA Device · Class II · 2013-09-11 · Boston Scientific - Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System
FDA Device · Class II · 2013-07-24 · Boston Scientific - NephroMax high Pressure nephrostomy Balloon Catheter Kit
FDA Device · Class II · 2013-07-17 · Boston Scientific - RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation Rigifl…
FDA Device · Class III · 2013-07-17 · Boston Scientific - NephroMax high Pressure Nephrostomy Balloon Catheter
FDA Device · Class II · 2013-07-17 · Boston Scientific - Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15)
FDA Device · Class II · 2012-10-24 · Boston Scientific