Boston Scientific Corp

• LIT — Cardiovascular38 devices
• FGE — Gastroenterology, Urology35 devices
• DQX — Cardiovascular23 devices
• DQO — Cardiovascular19 devices
• DSP — Cardiovascular14 devices
• DQY — Cardiovascular13 devices
• GEI — General, Plastic Surgery13 devices
• HCG — Neurology11 devices
• KNS — Gastroenterology, Urology9 devices
• DYB — Cardiovascular8 devices

• Z-0464-2016 — IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40; Catalog number: PM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia typically chronic, drug refractory atrial fibrillation.Class II·Terminated·2015-11-20
• Z-0465-2016 — IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia  typically chronic, drug refractory atrial fibrillation.Class II·Terminated·2015-11-20
• Z-0462-2016 — IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia  typically chronic, drug refractory atrial fibrillation.Class II·Terminated·2015-11-20
• Z-0463-2016 — IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Number: M004EPM4790N40; Catalog number: EPM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia typically chronic, drug refractory atrial fibrillation.Class II·Terminated·2015-11-20
• Z-0402-2016 — One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.Class II·Terminated·2015-09-11
• Z-1209-2015 — IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation The product is not approved for use/sale in the US.Class I·Terminated·2015-02-03
• Z-0580-2015 — IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.Class II·Terminated·2014-11-20

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170) +2 moreCode GEH·2024-10-18
• K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312)Code MXD·2023-08-19
• K152853 — WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic BiliaryCode FGE·2015-11-20
• K150692 — AXIOS Stent with Electrocautery Enhanced Delivery SystemCode PCU·2015-08-05
• K150303 — XXL Vascular Balloon Dilatation CatheterCode LIT·2015-06-15
• K150186 — Chariot Guiding SheathCode DYB·2015-06-05
• K150679 — EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit ConnectorCode PIF·2015-05-29
• K141820 — JAGWIRE HIGH PERFORMANCE GUIDWIRECode OCY·2014-10-21
• K141335 — EXPEL APD DRAINAGE CATHETER SYSTEMCode FGE·2014-10-17
• K141344 — EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEMCode FAD·2014-10-17
• K141150 — PTA BALLOON DILATATION CATHETERCode LIT·2014-09-25
• K142259 — Direxion Torqueable MicrocatheterCode KRA·2014-09-10
• K140273 — EQUALIZER OCCLUSION BALLOON CATHETERCode MJN·2014-07-22
• K140726 — CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIVCode FDI·2014-07-21
• K141185 — V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEMCode DQK·2014-06-06
• K140495 — LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODECode GEI·2014-04-17
• K140745 — ENCORE 26 ADVANTAGE KITCode MAV·2014-04-17
• K140288 — TRUEPATH CTO DEVICECode PDU·2014-04-16
• K140673 — INSERTION TOOLCode DQX·2014-04-16
• K132810 — GLADIATOR ELITE PTA BALLOON DILATATION CATHETERCode LIT·2014-02-28
• K133566 — ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUSCode MCW·2013-12-20
• K133208 — INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEMCode KRD·2013-11-14
• K131700 — SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARESCode FDI·2013-11-04
• K131914 — OFFROAD RE-ENTRY CATHETER SYSTEMCode PDU·2013-10-31
• K132990 — OCCLUSION BALLOON CATHETERCode MJN·2013-10-22
• K132947 — DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERSCode KRA·2013-10-18
• K132430 — STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETERCode LIT·2013-10-17
• K132578 — INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEMCode KRD·2013-09-13
• K130484 — MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETERCode FGE·2013-08-09
• K130391 — EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILATCode LOX·2013-07-10
• K130909 — GATEWAY ADVANAGE Y-ADAPTERCode OCX·2013-05-16
• K123621 — OPTICROSS 40 MHZ CORONARY IMAGING CATHETERCode OBJ·2013-04-15
• K130243 — ILAB ULTRASOUND IMAGING SYSTEMCode IYO·2013-03-01
• K123424 — MDU5 PLUS STERILE BAGCode ITX·2013-02-20
• K123535 — ILAB ULTRASOUND IMAGING SYSTEMCode IYO·2013-01-15
• K122794 — UPSYLON Y MESHCode OTO·2012-12-18
• K122649 — NAVIGATOR HD URETERAL ACCESS SHEATH SETCode FED·2012-12-12
• K123214 — ENCORE 26 ADVANTAGE KITCode MAV·2012-11-13
• K122924 — CRE FIXED WIRE BALLON DILATION CATHETERCode KNQ·2012-10-24
• K121754 — BLUE SUI SLINGCode OTN·2012-10-10
• K121614 — NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETERCode LJE·2012-09-18
• K121694 — IMAGER II ANGIOGRAPHIC CATHETERCode DQO·2012-09-14
• K121774 — ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUSCode MCW·2012-09-13
• K121196 — EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)Code LOX·2012-08-31
• K122394 — RUBICON 18 SUPPORT CATHETERCode DQY·2012-08-30
• K122203 — TRUETOMECode KNS·2012-08-17
• K121667 — NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)Code LOX·2012-08-13
• K121048 — ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVEREDCode JCT·2012-08-03
• K120495 — IMPULSE AND EXPO ANGIOGRAPHIC CATHETERCode DQO·2012-05-21
• K121186 — RADIAL JAW 4 PULMONARY BIOPSY FORCEPSCode BWH·2012-05-16
• K120694 — ENCORE 26 ADVANTAGE KITCode MAV·2012-04-03
• K120893 — IMAGER II ANGIOGRAPHIC CATHETERSCode DQO·2012-03-29
• K103426 — LITE PELVIC FLOOR REPAIR KITSCode OTP·2011-09-14
• K112103 — INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEMCode KRD·2011-08-12
• K111043 — ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETERCode OBJ·2011-08-04
• K111498 — FATHOM (TM) 14 STEERABLE GUIDEWIRECode DQX·2011-06-30
• K111252 — ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8FCode DQY·2011-06-02
• K110479 — ACUITY WHISPER VIEW GUIDE WIRESCode DQX·2011-04-08
• K110685 — FLEXIVA TRACTIPCode GEX·2011-03-29
• K110686 — ACCUTRACCode GEX·2011-03-28
• K110295 — INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEMCode KRD·2011-03-03
• K103355 — GDC 360 DETEACHABLE COILCode HCG·2011-02-16
• K102714 — COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICALCode KRD·2011-02-11
• K110030 — EXPECT ENDOSCOPIC ASPIRATION NEEDLECode ODG·2011-01-12
• K103008 — INZONE DETACHMENT SYSTEMCode HCG·2010-12-10
• K102672 — TARGET DETACHABLE COILCode HCG·2010-10-15
• K101657 — RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40Code KGE·2010-10-05
• K102082 — EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470Code FGE·2010-08-23
• K101314 — ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEMCode FGE·2010-07-23
• K101786 — ADVANIX DOUBLE PIGTAIL BILIARY STENTCode FGE·2010-07-23
• K100892 — RENEGADE HI-FLO FATHOM KIT MODEL M001182XXXCode KRA·2010-04-12
• K100078 — MODIFIED STRAIGHT FIRE LASER FIBERCode GEX·2010-02-12
• K093142 — TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEMCode HCG·2010-02-04
• K093636 — STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXXCode LIT·2009-12-23
• K093720 — STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIOCode LIT·2009-12-23
• K093691 — ACCUMAXCode GEX·2009-12-11
• K092666 — INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250Code HCG·2009-09-30
• K090554 — ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRECode DQX·2009-07-02
• K091340 — THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350Code FPD·2009-06-09
• K083374 — WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEMCode FGE·2009-04-22
• K090170 — SPYSCOPE ACCESS AND DELIVERY CATHETERCode ODF·2009-02-04
• K081576 — BLAZER DX-20 DIAGNOSTIC CATHETERCode DRF·2009-02-03
• K081739 — 2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KITCode KNT·2008-12-03
• K081733 — 10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890Code FGE·2008-10-27
• K082928 — STRAIGHT FIRE HOLMIUM LASER FIBERCode GEX·2008-10-16
• K081275 — BOSTON SCIENTIFIC SURGICAL MESHCode PAH·2008-08-27
• K081048 — PINNACLE PELVIC FLOOR REPAIR KIT IICode OTP·2008-08-22
• K081021 — KINETIX GUIDEWIRE, PLUS GUIDEWIRECode DQX·2008-08-08
• K080982 — STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERSCode LIT·2008-07-14
• K073623 — ATLANTIS 018 PERIPHERAL IMAGING CATHETERCode ITX·2008-03-13
• K080272 — ATLANTIS PVIMAGING CATHETER, MODEL H749364560Code ITX·2008-03-11
• K072719 — CONVOY ADVANCED DELIVERY SHEATHCode DYB·2008-03-07
• K073266 — WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEMCode ESW·2008-02-27
• K071957 — PINNACLE PELVIC FLOOR REPAIR KITSCode OTP·2007-11-08
• K072517 — ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3Code IYO·2007-09-26
• K071309 — BLUE MAX BALLOON DILATATION CATHETERCode LIT·2007-07-13
• K071634 — MODIFICATION TO:CONTOUR SE MICROSPHERESCode HCG·2007-07-12
• K071066 — SPYCATCH STONE RETRIEVAL BASKETCode LQR·2007-06-29
• K071042 — POLARCATH PERIPHERAL DILATATION SYSTEMCode LIT·2007-06-13
• K063493 — I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0Code IYN·2006-12-21