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Boston Scientific Recalls
651 recalls on record · June 27, 2012 to August 12, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 19, 2015Medical DevicesFDA
Boston Scientific Corporation recalls AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide.
Hazard: AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
August 19, 2015Medical DevicesFDA
Boston Scientific Corporation recalls AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide.
Hazard: AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
August 19, 2015Medical DevicesFDA
Boston Scientific Corporation recalls AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized.
Hazard: AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
August 19, 2015Medical DevicesFDA
Boston Scientific Corporation recalls AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide.
Hazard: AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
July 8, 2015Medical DevicesFDA
Boston Scientific Corporation recalls Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00
Hazard: One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label.
June 24, 2015Medical DevicesFDA
Boston Scientific Corporation recalls CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel nu
Hazard: Boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the CLEARSIGN II Amplifier, the surface Electrocardiogram (ECG) channels become over-written to a variable degree, with the result that it appears shifted from baseline on the system's output screen. This may, in turn, manifest as an uninterpretable ECG signal in the affected channel.
April 8, 2015Medical DevicesFDA
Boston Scientific Corporation recalls Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Hazard: Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retrieval using minimally invasive methods and, in some of the reported cases, this was performed to retrieve the device fragments.
April 8, 2015Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit,
Hazard: Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL Drainage Catheters. To date, Boston Scientific has received one complaint for device fragmentation after an Expel" APD catheter was implanted in the biliary system. The most serious foreseeable patient risk for this issue is additional intervention for fragment retrieval using minimally invasive meth
March 11, 2015Medical DevicesFDA
Boston Scientific Corp recalls IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM962
Hazard: Reports of formation of char adherent to the proximal part of the distal tip electrodes
January 21, 2015Medical DevicesFDA
Boston Scientific Corporation recalls Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LT
Hazard: Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If this occurs, the first valve could embolize and it may be necessary to convert the patient to surgery.
January 21, 2015Medical DevicesFDA
Boston Scientific Corporation recalls Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LT
Hazard: Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If this occurs, the first valve could embolize and it may be necessary to convert the patient to surgery.
January 21, 2015Medical DevicesFDA
Boston Scientific Corporation recalls Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LT
Hazard: Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If this occurs, the first valve could embolize and it may be necessary to convert the patient to surgery.
December 17, 2014Medical DevicesFDA
Boston Scientific Corp recalls IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated f
Hazard: Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field.
October 15, 2014Medical DevicesFDA
Boston Scientific Corporation recalls StarMedTec LightTrail¿ Reusable Fibers, 800 um; Material/Part Number: 6457
Hazard: Product is not cleared for use with lasers other than the Auriga XL system
October 15, 2014Medical DevicesFDA
Boston Scientific Corporation recalls StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455
Hazard: Product is not cleared for use with lasers other than the Auriga XL system
October 15, 2014Medical DevicesFDA
Boston Scientific Corporation recalls StarMedTec LightTrail¿ Reusable Fibers, 365 um; Material/Part Number: 6453
Hazard: Product is not cleared for use with lasers other than the Auriga XL system
June 25, 2014Medical DevicesFDA
Boston Scientific Corporation recalls IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessor
Hazard: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
June 25, 2014Medical DevicesFDA
Boston Scientific Corporation recalls IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve. The BSC Controller and Accessories a
Hazard: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
June 25, 2014Medical DevicesFDA
Boston Scientific Corporation recalls IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessorie
Hazard: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
June 25, 2014Medical DevicesFDA
Boston Scientific Corporation recalls IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The BSC Controller and Accesso
Hazard: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
June 25, 2014Medical DevicesFDA
Boston Scientific Corporation recalls IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories
Hazard: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
June 25, 2014Medical DevicesFDA
Boston Scientific Corporation recalls IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessorie
Hazard: Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
April 30, 2014Medical DevicesFDA
Boston Scientific Corporation recalls iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular path
Hazard: Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the Longview distance measurement may display an inaccurate value that is double the actual distance.
March 19, 2014Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Hazard: The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.
February 19, 2014Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
Hazard: Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. T
February 19, 2014Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-251
Hazard: Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. T
February 5, 2014Medical DevicesFDA
Boston Scientific Corporation recalls Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usag
Hazard: Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.
January 22, 2014Medical DevicesFDA
Boston Scientific Corporation recalls TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a
Hazard: Sterility of device may be compromised due to lack of pouch seal integrity
January 22, 2014Medical DevicesFDA
Boston Scientific Corporation recalls TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. Dist
Hazard: Sterility of device may be compromised due to lack of pouch seal integrity
January 22, 2014Medical DevicesFDA
Boston Scientific Corporation recalls TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Dist
Hazard: Sterility of device may be compromised due to lack of pouch seal integrity