Boston Scientific Corporation
Maple Grove, MN
This page shows every FDA and USDA recall linked to Boston Scientific Corporation. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
353
Total Recalls
2008
First Recall
2026
Most Recent
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F,
1) 2.5mm x120mm, 150 cm, UPM/Model...
Jan 9, 2026
· Device
Open, Classified
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, F...
Sep 11, 2025
· Device
Open, Classified
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Sep 11, 2025
· Device
Open, Classified
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN):
1. H74904526011;
2. H74904526052;
3....
Sep 5, 2025
· Device
Open, Classified
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN):
1. M0062251200,
2. M0062251210,
3. M0062251220...
Sep 5, 2025
· Device
Open, Classified
Boston Scientific Encore Advantage Kit, Material Numbers (UPN):
1. H74904527011;
2. H74904527052.
(Inter...
Sep 5, 2025
· Device
Open, Classified
Boston Scientific NephroMax Kit, Material Numbers (UPN):
1. M0062101180;
2. M0062101600.
(Urology)
Sep 5, 2025
· Device
Open, Classified
WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and tr...
Aug 29, 2025
· Device
Open, Classified
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and tr...
Aug 29, 2025
· Device
Open, Classified
WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and t...
Aug 29, 2025
· Device
Open, Classified
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and...
Aug 29, 2025
· Device
Open, Classified
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and tr...
Aug 29, 2025
· Device
Open, Classified
WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transs...
Aug 29, 2025
· Device
Open, Classified
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and tr...
Aug 29, 2025
· Device
Open, Classified
WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and...
Aug 29, 2025
· Device
Open, Classified
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and tr...
Aug 29, 2025
· Device
Open, Classified
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and t...
Aug 29, 2025
· Device
Open, Classified
WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and t...
Aug 29, 2025
· Device
Open, Classified
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system....
Aug 8, 2025
· Device
Open, Classified
IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170.
The needles are intended to convert high-pr...
Apr 29, 2025
· Device
Open, Classified
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100.
The needles are intended to convert high...
Apr 29, 2025
· Device
Open, Classified
IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170.
The needles are intended to convert high-p...
Apr 29, 2025
· Device
Open, Classified
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100.
The needles are intended to convert high-...
Apr 29, 2025
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; the system ut...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system u...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE US; the system utili...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system ut...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW; the system utiliz...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US; the system utili...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the system utilizes an in...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW; the system utilizes an...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an inter...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system u...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE EU ROW; the system u...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an in...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system ut...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilize...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an inter...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utili...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system ut...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US; the system utili...
Oct 16, 2024
· Device
Open, Classified
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system...
Oct 16, 2024
· Device
Open, Classified
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with...
Sep 13, 2024
· Device
Open, Classified
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drai...
Sep 13, 2024
· Device
Open, Classified
vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for u...
Sep 13, 2024
· Device
Open, Classified
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage...
Sep 13, 2024
· Device
Open, Classified
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-pu...
Sep 13, 2024
· Device
Open, Classified