Boston Scientific Corporation: 296 recalls on record

Recalls filed with 1 agency: FDA (296).

First recall on record: June 27, 2012. Most recent: September 23, 2026.

Risk classification: Class I: 73 · Class II: 221 · Class III: 2

Most recent recalls

DateAgencyProduct
March 15, 2017FDAAngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascul…Z-1401-2017
February 15, 2017FDABoston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.Z-1178-2017
January 11, 2017FDABoston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.Z-0938-2017
April 20, 2016FDABoston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Steri…Z-1370-2016
January 20, 2016FDABoston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradyca…Z-0620-2016
November 18, 2015FDARotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra S…Z-0212-2016
November 18, 2015FDARotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy.…Z-0211-2016
April 8, 2015FDAVarious Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and B…Z-1355-2015
October 15, 2014FDAStarMedTec LightTrail¿ Reusable Fibers, 800 um; Material/Part Number: 6457Z-0051-2015
October 15, 2014FDAStarMedTec LightTrail¿ Reusable Fibers, 365 um; Material/Part Number: 6453Z-0049-2015
October 15, 2014FDAStarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455Z-0050-2015
June 25, 2014FDAIntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve. The B…Z-1798-2014
June 25, 2014FDAIntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. …Z-1796-2014
June 25, 2014FDAIntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. Th…Z-1794-2014
June 25, 2014FDAIntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. Th…Z-1797-2014
June 25, 2014FDAIntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The …Z-1795-2014
June 25, 2014FDAIntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. …Z-1799-2014
April 30, 2014FDAiLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound exa…Z-1487-2014
March 19, 2014FDABoston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.Z-1164-2014
February 19, 2014FDABoston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H749391852015…Z-0971-2014
February 19, 2014FDABoston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H7493…Z-0969-2014
February 5, 2014FDAAtlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irr…Z-0900-2014
January 22, 2014FDATWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product…Z-0721-2014
January 22, 2014FDABoston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN:…Z-0710-2014
January 22, 2014FDATWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be u…Z-0724-2014

Questions about this company

How many recalls does Boston Scientific Corporation have?
Recalert has 296 U.S. recalls on record for Boston Scientific Corporation, published between June 27, 2012 and September 23, 2026.
Which agencies have handled Boston Scientific Corporation recalls?
Boston Scientific Corporation appears as the recalling firm in recalls from: FDA (296).

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