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Boston Scientific Corporation

890 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273 recall (Z-2019-2021)Boston Scientific Corporation2021-07-13
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021) recall (Z-2020-2021)Boston Scientific Corporation2021-07-13
Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131 recall (Z-1998-2021)Boston Scientific Corporation2021-07-02
Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231 recall (Z-1999-2021)Boston Scientific Corporation2021-07-02
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331 recall (Z-2000-2021)Boston Scientific Corporation2021-07-02
Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722 recall (Z-2001-2021)Boston Scientific Corporation2021-07-02
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128 recall (Z-2002-2021)Boston Scientific Corporation2021-07-02
VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228 recall (Z-2003-2021)Boston Scientific Corporation2021-07-02
EMBLEM S-ICD Model A209 recall (Z-0950-2021)Boston Scientific Corporation2021-02-05
EMBLEM MRI S-ICD Model A219 recall (Z-0951-2021)Boston Scientific Corporation2021-02-05
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defi recall (Z-0879-2021)Boston Scientific Corporation2021-01-19
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery Syst recall (Z-0728-2021)Boston Scientific Corporation2021-01-09
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery Syst recall (Z-0729-2021)Boston Scientific Corporation2021-01-09
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery Syst recall (Z-0730-2021)Boston Scientific Corporation2021-01-09
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery Syst recall (Z-0734-2021)Boston Scientific Corporation2021-01-09
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery Syst recall (Z-0735-2021)Boston Scientific Corporation2021-01-09
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery Syst recall (Z-0736-2021)Boston Scientific Corporation2021-01-09
AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connect recall (Z-0427-2021)Boston Scientific Corporation2020-11-06
Imager II 5F Angiographic Catheters, 5 units per package. recall (Z-1555-2020)Boston Scientific Corporation2020-03-25
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scie recall (Z-1511-2020)Boston Scientific Corporation2020-03-03
Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - recall (Z-1512-2020)Boston Scientific Corporation2020-03-03
AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: in recall (Z-2045-2020)Boston Scientific Corporation2020-01-28
AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 10565 recall (Z-0717-2020)Boston Scientific Corporation2019-12-19
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M0053661 recall (Z-0548-2020)Boston Scientific Corporation2019-11-25
Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620 recall (Z-0549-2020)Boston Scientific Corporation2019-11-25
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M0053663 recall (Z-0550-2020)Boston Scientific Corporation2019-11-25
Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640 recall (Z-0551-2020)Boston Scientific Corporation2019-11-25
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M0053665 recall (Z-0552-2020)Boston Scientific Corporation2019-11-25
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm UPN: M0053666 recall (Z-0553-2020)Boston Scientific Corporation2019-11-25
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M0053667 recall (Z-0554-2020)Boston Scientific Corporation2019-11-25
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336 recall (Z-0555-2020)Boston Scientific Corporation2019-11-25
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336 recall (Z-0556-2020)Boston Scientific Corporation2019-11-25
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M005367 recall (Z-0557-2020)Boston Scientific Corporation2019-11-25
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M005367 recall (Z-0558-2020)Boston Scientific Corporation2019-11-25
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN: M005337 recall (Z-0559-2020)Boston Scientific Corporation2019-11-25
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M005367 recall (Z-0560-2020)Boston Scientific Corporation2019-11-25
AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser recall (Z-1391-2019)Boston Scientific Corporation2019-05-22
AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser S recall (Z-1392-2019)Boston Scientific Corporation2019-05-22
AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL 4007 recall (Z-1393-2019)Boston Scientific Corporation2019-05-22
AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: The Auriga XL 4007 recall (Z-1394-2019)Boston Scientific Corporation2019-05-22
AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and recall (Z-1395-2019)Boston Scientific Corporation2019-05-22
AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser recall (Z-1396-2019)Boston Scientific Corporation2019-05-22
AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System an recall (Z-1397-2019)Boston Scientific Corporation2019-05-22
AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Auriga XL 4007 Laser S recall (Z-1398-2019)Boston Scientific Corporation2019-05-22
AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007 Lase recall (Z-1399-2019)Boston Scientific Corporation2019-05-22
Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbe recall (Z-0202-2019)Boston Scientific Corporation2018-08-28
Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturi recall (Z-1616-2018)Boston Scientific Corporation2018-05-04
Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications du recall (Z-1617-2018)Boston Scientific Corporation2018-05-04
Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transv recall (Z-1618-2018)Boston Scientific Corporation2018-05-04
Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general sutur recall (Z-1619-2018)Boston Scientific Corporation2018-05-04
Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing recall (Z-1620-2018)Boston Scientific Corporation2018-05-04
Capio RP; Model #M0068321010. Intended for use in general suturing applications during ope recall (Z-1621-2018)Boston Scientific Corporation2018-05-04
Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women recall (Z-1622-2018)Boston Scientific Corporation2018-05-04
Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in wo recall (Z-1623-2018)Boston Scientific Corporation2018-05-04
PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement recall (Z-1624-2018)Boston Scientific Corporation2018-05-04
PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in wo recall (Z-1625-2018)Boston Scientific Corporation2018-05-04
Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in w recall (Z-1626-2018)Boston Scientific Corporation2018-05-04
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical recall (Z-0897-2018)Boston Scientific Corporation2018-03-05
Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in recall (Z-0898-2018)Boston Scientific Corporation2018-03-05
Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description a recall (Z-0685-2018)Boston Scientific Corporation2018-02-22
Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as recall (Z-0686-2018)Boston Scientific Corporation2018-02-22
EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product recall (Z-3037-2017)Boston Scientific Corporation2017-08-16
EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Produ recall (Z-3038-2017)Boston Scientific Corporation2017-08-16
SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide def recall (Z-3039-2017)Boston Scientific Corporation2017-08-16
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media recall (Z-2645-2017)Boston Scientific Corporation2017-06-27
The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking an recall (Z-1922-2017)Boston Scientific Corporation2017-04-10
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), recall (Z-1781-2017)Boston Scientific Corporation2017-03-23
Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR recall (Z-2749-2016)Boston Scientific Corporation2016-09-07
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 recall (Z-1342-2016)Boston Scientific Corporation2016-04-18
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia recall (Z-0620-2016)Boston Scientific Corporation2016-01-08
Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia recall (Z-0621-2016)Boston Scientific Corporation2016-01-08
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, recall (Z-0588-2016)Boston Scientific Corporation2016-01-05
Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product recall (Z-0392-2016)Boston Scientific Corporation2015-12-18
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. recall (Z-0211-2016)Boston Scientific Corporation2015-11-13
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Su recall (Z-0212-2016)Boston Scientific Corporation2015-11-13
Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to prov recall (Z-0232-2016)Boston Scientific Corporation2015-11-06
AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Steri recall (Z-2377-2015)Boston Scientific Corporation2015-08-13
AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Ste recall (Z-2378-2015)Boston Scientific Corporation2015-08-13
AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Usi recall (Z-2379-2015)Boston Scientific Corporation2015-08-13
AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylen recall (Z-2380-2015)Boston Scientific Corporation2015-08-13
Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Univ recall (Z-1941-2015)Boston Scientific Corporation2015-07-01
CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware recall (Z-1817-2015)Boston Scientific Corporation2015-06-18
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Bi recall (Z-1355-2015)Boston Scientific Corporation2015-03-31
Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and recall (Z-1336-2015)Boston Scientific Corporation2015-03-27
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Ster recall (Z-0915-2015)Boston Scientific Corporation2015-01-13
Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Ster recall (Z-0916-2015)Boston Scientific Corporation2015-01-13
Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Ster recall (Z-0917-2015)Boston Scientific Corporation2015-01-13
StarMedTec LightTrail Reusable Fibers, 365 um; Material/Part Number: 6453 recall (Z-0049-2015)Boston Scientific Corporation2014-10-08
StarMedTec LightTrail Reusable Fibers, 600 um; Material/Part Number: 6455 recall (Z-0050-2015)Boston Scientific Corporation2014-10-08
StarMedTec LightTrail Reusable Fibers, 800 um; Material/Part Number: 6457 recall (Z-0051-2015)Boston Scientific Corporation2014-10-08
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BS recall (Z-1794-2014)Boston Scientific Corporation2014-06-16
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC recall (Z-1795-2014)Boston Scientific Corporation2014-06-16
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The recall (Z-1796-2014)Boston Scientific Corporation2014-06-16
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BS recall (Z-1797-2014)Boston Scientific Corporation2014-06-16
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve. The BSC C recall (Z-1798-2014)Boston Scientific Corporation2014-06-16
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The recall (Z-1799-2014)Boston Scientific Corporation2014-06-16
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound exami recall (Z-1487-2014)Boston Scientific Corporation2014-04-22
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664. recall (Z-1164-2014)Boston Scientific Corporation2014-03-10
Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H749391 recall (Z-0969-2014)Boston Scientific Corporation2014-02-11
Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H7493918520151 recall (Z-0971-2014)Boston Scientific Corporation2014-02-11
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