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Boston Scientific Corporation

890 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; car recall (Z-1641-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; car recall (Z-1642-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; recall (Z-1643-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; ca recall (Z-1644-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712; c recall (Z-1645-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; recall (Z-1646-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; ca recall (Z-1647-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; ca recall (Z-1648-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; car recall (Z-1649-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; ca recall (Z-1650-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; ca recall (Z-1651-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; card recall (Z-1652-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; c recall (Z-1653-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H7490852622 recall (Z-1654-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; car recall (Z-1655-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H7490852622 recall (Z-1656-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H7490852623 recall (Z-1657-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; c recall (Z-1658-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H7490852623 recall (Z-1659-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H74908526240 recall (Z-1660-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; c recall (Z-1661-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; car recall (Z-1662-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; recall (Z-1663-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; c recall (Z-1664-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H7490852630 recall (Z-1665-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H74908526 recall (Z-1666-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085 recall (Z-1667-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H7490 recall (Z-1668-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H7490 recall (Z-1669-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H7490 recall (Z-1670-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; card recall (Z-1671-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; card recall (Z-1672-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H7490 recall (Z-1673-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; car recall (Z-1674-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; car recall (Z-1675-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2 recall (Z-1676-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; recall (Z-1677-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2 recall (Z-1678-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; recall (Z-1679-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; car recall (Z-1680-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; car recall (Z-1681-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; recall (Z-1682-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; car recall (Z-1683-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; car recall (Z-1684-2024)Boston Scientific Corporation2024-05-10
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; card recall (Z-1685-2024)Boston Scientific Corporation2024-05-10
EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly recall (Z-1513-2024)Boston Scientific Corporation2024-04-11
EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition direct recall (Z-1514-2024)Boston Scientific Corporation2024-04-11
EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into th recall (Z-1515-2024)Boston Scientific Corporation2024-04-11
EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into recall (Z-1516-2024)Boston Scientific Corporation2024-04-11
EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directl recall (Z-1517-2024)Boston Scientific Corporation2024-04-11
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral recall (Z-1390-2024)Boston Scientific Corporation2024-03-28
OptiCross Coronary Imaging Catheter, REF H749518080120 recall (Z-1396-2024)Boston Scientific Corporation2024-03-28
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010 recall (Z-1374-2024)Boston Scientific Corporation2024-03-27
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 recall (Z-1302-2024)Boston Scientific Corporation2024-03-26
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510. recall (Z-1153-2024)Boston Scientific Corporation2024-02-16
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed wit recall (Z-0673-2024)Boston Scientific Corporation2024-01-05
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242C recall (Z-0396-2024)Boston Scientific Corporation2023-11-21
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M recall (Z-0397-2024)Boston Scientific Corporation2023-11-21
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac gui recall (Z-0009-2024)Boston Scientific Corporation2023-10-03
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac gui recall (Z-0010-2024)Boston Scientific Corporation2023-10-03
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac gui recall (Z-0011-2024)Boston Scientific Corporation2023-10-03
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac gui recall (Z-0012-2024)Boston Scientific Corporation2023-10-03
Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac gui recall (Z-0013-2024)Boston Scientific Corporation2023-10-03
Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac gui recall (Z-0014-2024)Boston Scientific Corporation2023-10-03
Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac gui recall (Z-0015-2024)Boston Scientific Corporation2023-10-03
Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac gui recall (Z-0016-2024)Boston Scientific Corporation2023-10-03
Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac gu recall (Z-0017-2024)Boston Scientific Corporation2023-10-03
Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac gu recall (Z-0018-2024)Boston Scientific Corporation2023-10-03
Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac gu recall (Z-0019-2024)Boston Scientific Corporation2023-10-03
Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac gu recall (Z-0020-2024)Boston Scientific Corporation2023-10-03
Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac gu recall (Z-0021-2024)Boston Scientific Corporation2023-10-03
Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac gu recall (Z-0022-2024)Boston Scientific Corporation2023-10-03
Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac gu recall (Z-0023-2024)Boston Scientific Corporation2023-10-03
Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac gu recall (Z-0024-2024)Boston Scientific Corporation2023-10-03
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillat recall (Z-2441-2023)Boston Scientific Corporation2023-08-22
EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibri recall (Z-2442-2023)Boston Scientific Corporation2023-08-22
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits H recall (Z-2228-2023)Boston Scientific Corporation2023-07-21
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that t recall (Z-2229-2023)Boston Scientific Corporation2023-07-21
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that tr recall (Z-2230-2023)Boston Scientific Corporation2023-07-21
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from c recall (Z-2231-2023)Boston Scientific Corporation2023-07-21
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from c recall (Z-2232-2023)Boston Scientific Corporation2023-07-21
Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits recall (Z-2233-2023)Boston Scientific Corporation2023-07-21
Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmi recall (Z-2234-2023)Boston Scientific Corporation2023-07-21
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner recall (Z-1592-2023)Boston Scientific Corporation2023-05-16
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (in recall (Z-1593-2023)Boston Scientific Corporation2023-05-16
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) cathe recall (Z-1397-2023)Boston Scientific Corporation2023-04-18
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6 recall (Z-1216-2023)Boston Scientific Corporation2023-03-03
ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic proce recall (Z-0224-2023)Boston Scientific Corporation2022-11-11
ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal end recall (Z-0225-2023)Boston Scientific Corporation2022-11-11
ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures recall (Z-0226-2023)Boston Scientific Corporation2022-11-11
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile. recall (Z-0151-2023)Boston Scientific Corporation2022-10-31
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile. recall (Z-0152-2023)Boston Scientific Corporation2022-10-31
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a comp recall (Z-0149-2023)Boston Scientific Corporation2022-10-28
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440 recall (Z-1582-2022)Boston Scientific Corporation2022-08-25
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE) recall (Z-2327-2021)Boston Scientific Corporation2021-08-19
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE) recall (Z-2328-2021)Boston Scientific Corporation2021-08-19
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K0 recall (Z-2015-2021)Boston Scientific Corporation2021-07-13
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K1 recall (Z-2016-2021)Boston Scientific Corporation2021-07-13
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K27 recall (Z-2017-2021)Boston Scientific Corporation2021-07-13
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173 recall (Z-2018-2021)Boston Scientific Corporation2021-07-13
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Every clearance here is in the API, with alerts when new ones post.