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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.
January 22, 2014Medical DevicesFDA
Boston Scientific Corporation recalls TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Distr
Hazard: Sterility of device may be compromised due to lack of pouch seal integrity
January 22, 2014Medical DevicesFDA
Boston Scientific Corporation recalls TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. 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 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Dis
Hazard: Sterility of device may be compromised due to lack of pouch seal integrity
January 22, 2014Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140
Hazard: Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
January 22, 2014Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
Hazard: Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
January 22, 2014Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro X
Hazard: Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
December 11, 2013Medical DevicesFDA
Boston Scientific Corporation recalls Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Ind
Hazard: The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
December 11, 2013Medical DevicesFDA
Boston Scientific Corporation recalls Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indi
Hazard: The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
December 11, 2013Medical DevicesFDA
Boston Scientific Corporation recalls Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile. Ind
Hazard: The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
September 11, 2013Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting
Hazard: Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the devic
September 11, 2013Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon
Hazard: Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the devic
July 24, 2013Medical DevicesFDA
Boston Scientific Corporation recalls Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS
Hazard: Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters. The expiration date indicated on the inner tray, 2012-04, is incorrect. The correct expiration date is 2014-04 as indicated on the outer box label.
July 17, 2013Medical DevicesFDA
Boston Scientific Corporation recalls NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M006210
Hazard: Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
July 17, 2013Medical DevicesFDA
Boston Scientific Corporation recalls NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/21
Hazard: Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
July 17, 2013Medical DevicesFDA
Boston Scientific Corporation recalls RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scient
Hazard: Product labeled with incorrect expiration date.
October 24, 2012Medical DevicesFDA
Boston Scientific Corporation recalls Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with
Hazard: Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.
October 24, 2012Medical DevicesFDA
Boston Scientific Corporation recalls Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar, electrosurgical devices, intended fo
Hazard: Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.
October 24, 2012Medical DevicesFDA
Boston Scientific Corporation recalls LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25
Hazard: Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.
June 27, 2012Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The sing
Hazard: Difficulty in extending snare loop from the catheter
June 27, 2012Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The sing
Hazard: Difficulty in extending snare loop from the catheter
June 27, 2012Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The sin
Hazard: Difficulty in extending snare loop from the catheter