FDA (Devices) recall action 94240

Boston Scientific Corporation recalled 48 products on 2024-05-22

The FDA (Devices) publishes a recall like this one as 48 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 48 pages.

Products: 48
Announced: 2024-05-22
Critical: 5
Units: 1,048,538

Why these products were recalled

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–48 of 48

SevereFDA (Devices)··2024-05-22
Expo Cardiac Catheters Recalled Due to Delamination and Guidewire Advancement Failure
Boston Scientific has recalled Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The defect affects certain batch numbers in catheters distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter
Category
Distribution
0 states
CriticalFDA (Devices)··2024-05-22
Expo 5F Cardiac Catheters recalled due to polyurethane delamination
Boston Scientific recalled 2,314 Expo 5F cardiac catheters due to polyurethane delamination in the inner lining. The defect can prevent guidewire advancement during angiographic procedures.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Expo Cardiac Catheters Recalled Due to Polyurethane Delamination and Material Detachment
Boston Scientific's Expo 5F Selective Angiographic Catheters are being recalled worldwide because the polyurethane layer is delaminating and detaching from the inner lining, preventing the guidewire from advancing through the device.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Cardiac Catheters Recalled for Material Delamination Risk
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters worldwide due to polyurethane delamination and material detachment that prevents guidewire advancement.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Expo 5F Selective Angiographic Catheters Recalled for Material Delamination
Boston Scientific is recalling Expo 5F catheters due to polyurethane delamination and material detachment preventing guidewire advancement. The recall affects approximately 16,797 catheters distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Expo 5F Selective Angiographic Catheters recalled due to material delamination
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters in certain batches due to polyurethane layer delamination that prevents guidewire advancement. The inner lining material may detach, making the catheters unsafe to use.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Expo 5F Selective Angiographic Catheters Recalled for Material Delamination
Boston Scientific recalled Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in certain batches, which can prevent guidewire advancement during cardiac procedures.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Boston Scientific Cardiac Catheters Recalled for Inner Lining Delamination
Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the inner lining, which can prevent guidewire advancement.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Cardiac catheters recalled due to polyurethane layer delamination defects
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer defects that prevent proper guidewire insertion. Affected devices may experience material detachment in the catheter lining.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Expo selective angiographic cardiac catheters recalled for guidewire advancement failure
Boston Scientific is recalling Expo 5F selective angiographic catheters due to polyurethane layer delamination and material detachment that prevents guidewire advancement through the device.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Expo 5F cardiac catheters recalled for material delamination
Boston Scientific Corporation recalls Expo 5F cardiac catheters due to polyurethane layer delamination and inner lining detachment that prevents guidewire advancement. Affected batch 60535890 has been distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheter
Category
Distribution
0 states
CriticalFDA (Devices)··2024-05-22
Boston Scientific cardiac catheters recalled for delaminating polyurethane and guidewire advancement failure
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to complaints of guidewire advancement problems and polyurethane delamination in the catheter lining. Affected catheters are distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Boston Scientific Cardiac Catheters Recalled for Material Delamination
Boston Scientific recalled Expo 5F cardiac catheters due to polyurethane delamination preventing guidewire advancement. The defect may cause device failure during medical procedures.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Boston Scientific cardiac catheters recalled for polyurethane delamination
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. Approximately 37,252 catheters in specific batches are affected worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Expo 5F Cardiac Catheters recalled due to delamination defect
Boston Scientific is recalling 8,715 Expo 5F Selective Angiographic Catheters in certain batches due to polyurethane delamination that prevents guidewire advancement. The affected units were distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Angiographic Catheters Recalled for Polyurethane Delamination and Malfunction
Boston Scientific recalls Expo 5F angiographic catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The recall affects 3,127 units in specific batches distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Expo 5F cardiac angiographic catheters recalled for delamination defect
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination that prevents guidewire advancement through the catheter lumen.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Boston Scientific Expo 5F Catheters recalled due to material delamination defect
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement during cardiac procedures.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Expo 5F Selective Angiographic Catheters recalled for guidewire advancement failure
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination that can prevent guidewire advancement during cardiac catheterization procedures.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Expo 5F cardiac catheters recalled for material delamination worldwide
Boston Scientific is recalling 2,990 Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination that prevents guidewire advancement through the device lumen.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H749085262202; cardiac catheter
Category
Distribution
0 states
CriticalFDA (Devices)··2024-05-22
Expo Selective Angiographic Catheters Recalled for Material Delamination and Detachment
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that may prevent guidewire advancement during cardiac procedures. Affected batches 60443927 and 60495422 have been distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Expo 5F Catheters Recalled for Guidewire Advancement Failure
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. The issue affects 440 catheters distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter
Category
Distribution
0 states
SevereFDA (Devices)··2024-05-22
Boston Scientific Expo 5F Cardiac Catheters Recalled for Delamination Defect
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination that prevents guidewire advancement during cardiac procedures. The recall affects 86,898 catheters distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter
Category
Distribution
0 states