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Boston Scientific Corporation One Boston

Boston Scientific Corporation One Boston Recalls

All product recalls associated with Boston Scientific Corporation One Boston.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 18721–18740 of 21320 recalls

Boston Scientific Corporation One Boston: Boston Scientific NexStent Monorail 5F Carotid Stent and...

Boston Scientific NexStent Carotid Stent device failed to deploy when the outer catheter (proximal outer and distal sheath) did not pull back and expose the self-expanding stent.

FDAMay 1, 2007Nationwide• Boston Scientific Corporation One Boston

Possis Medical, Inc: Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use onl...

Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.

FDAMay 1, 2007Nationwide• Possis Medical, Inc

Possis Medical, Inc: Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Sin...

Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.

1...935 936937938 939...1066

Page 937 of 1066Next

FDA

May 1, 2007

Nationwide

• Possis Medical, Inc

Boston Scientific Corporation One Boston: Boston Scientific Scimed Maverick 2 Monorail" PTCA Cath...

The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.

FDAMay 1, 2007Nationwide• Boston Scientific Corporation One Boston

Roche Diagnostics Corp.: Roche VANC2, Online TDM Vancomycin, for use with the Roch...

Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.

FDAApr 30, 2007Nationwide• Roche Diagnostics Corp.

Siemens Medical Solutions USA, Inc.: c.cam Gamma Camera, Model 9VIR1200; Siemens Medical Solut...

Chair Breakage: Under extreme load, the chair back of the c.cam emission computed tomography system may bend and eventually break. This could be caused by the accumulated stress from heavy patients seating or stretching themselves in the chair or simply from long time use.

FDAApr 30, 2007Nationwide• Siemens Medical Solutions USA, Inc.

Philips Medical Systems North America Co. Phillips: Achieva MRI

Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

FDAApr 30, 2007Nationwide• Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips: Gyroscan MRI

Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

FDAApr 30, 2007Nationwide• Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips: Intera MRI

Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

FDAApr 30, 2007Nationwide• Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips: Panorama 1.0T MRI

Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

FDAApr 30, 2007Nationwide• Philips Medical Systems North America Co. Phillips

Roche Diagnostics Corp.: Roche VALP2, Online TDM Valproic acid , for use with the ...

FDAApr 30, 2007Nationwide• Roche Diagnostics Corp.

Philips Medical Systems (Cleveland) Inc: The product is an isolation transformer, an accessory to ...

Fire/Burn Risk

The TEAL Power Conditioning units may fail and result in the unit emitting fire and/or smoke. Note: the TEAL Power Conditioning Unit has the potential to fail when the scanner that is attached to the TEAL is powered and in use as well as when not in use.

FDAApr 27, 2007Nationwide• Philips Medical Systems (Cleveland) Inc

Medtronic MiniMed: Medtronic MiniMed Paradigm Insulin Infusion Pumps for the...

Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemi

FDAApr 27, 2007PR• Medtronic MiniMed

Medtronic Emergency Response Systems, Inc.: LIFEPAK 20 defibrillator/monitor. The device is an AC pow...

White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment.

FDAApr 27, 2007IN, OR• Medtronic Emergency Response Systems, Inc.

Ortho-Clinical Diagnostics: VITROS Immunodiagnostic Products Troponin I Reagent Pack,...

Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in the device failing to detect myocardial injury.

FDAApr 27, 2007Nationwide• Ortho-Clinical Diagnostics

Philips Medical Systems: HD11XE Diagnostic Ultrasound System

Potential for erroneous measurements which may lead to incorrect diagnosis based upon the presence of an inaccurate, undetectable error in clinical measurement or calculation. If the user exits an imaging mode while Active Annotation is in use, the system can enter an undefined state where the image scale calibration may not match the scale of the on-screen measurements and graphics and possib

FDAApr 25, 2007Nationwide• Philips Medical Systems

Becton Dickinson & Company: BD AutoShield Pen Needle (Re order Number : 329300)

Needle Sticks: Complaints were received regarding Needle Stick Injuries while administering insulin to patients. (Labeling will be revised to provide clear direction on product usage)

FDAApr 23, 2007Nationwide• Becton Dickinson & Company

Sunrise Medical Inc: Sunrise Medical Quickie Power Wheelchairs: Three models -...

The wire harness connected to the display housing (Quickie IQ Enhanced Displays) may separate and cause sparks from a short circuit.

FDAApr 23, 2007Nationwide• Sunrise Medical Inc

Pml Microbiologicals Inc.: Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MC...

Plates manufactured without vancomycin. Possibility for false resistant results.

FDAApr 23, 2007Nationwide• Pml Microbiologicals Inc.

Ethicon, Inc. US: Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethico...

The pre-printed outer box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor System (Product Code PFRT01). The contents of the box actually contain GYNECARE PROLIFT Anterior Pelvic Floor System (Product Code PFRA01)

FDAApr 20, 2007Nationwide• Ethicon, Inc. US