Hazard

Embolization recalls

69 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 69
Critical: 10
Severe: 47
Most recent: 2024-05-15

Of the 69 embolization recalls we have scored against our rubric, 10 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 47 (68%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all embolization recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

51–69 of 69

HighFDA (Devices)·Z-2143-2020·2020-06-03
Spectranetics Bridge Occlusion Balloon Recalled for Thrombus Formation Risk
Spectranetics is recalling Bridge Occlusion Balloons because current labeling is insufficient to warn users about the risk of thrombus formation if the device remains in the vasculature for long durations.
Product
Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0293-2018·2018-01-17
Edwards Certitude Delivery System Recalled for Molding Overflow Defect
Edwards Lifesciences is recalling 1,730 units of the Certitude Delivery System due to a molding overflow defect that could detach and embolize into patients.
Product
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA) o
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-2612-2016·2016-08-31
Cook Inc. Recalls Beacon Tip Catheters Due to Tip Fracture Risk
Cook Inc. is recalling Beacon Tip catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.
Product
Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2613-2016·2016-08-31
Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Fracture
Cook Inc. is recalling 60,302 Shuttle Select Slip-Cath catheters worldwide due to polymer degradation causing tip fracture and separation.
Product
Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2621-2016·2016-08-31
Cook Inc. Recalls Selective Salpingography Catheters Due to Tip Fracture Risk
Cook Inc. is recalling 7,819 Selective Salpingography Catheters with Beacon Tip due to polymer degradation that can cause the catheter tip to fracture or separate.
Product
Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contrast medium into the fallopian tube(s) for selective salpingography.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2623-2016·2016-08-31
Cook Inc. Recalls White Lumax Guiding Coaxial Catheters Due to Tip Fracture
Cook Inc. is recalling 3,425 White Lumax Guiding Coaxial Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.
Product
White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2618-2016·2016-08-31
Cook Inc. Recalls Liver Access and Biopsy Needle Sets Due to Tip Fracture
Cook Inc. is recalling 52,756 Liver Access and Biopsy Needle Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.
Product
Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2610-2016·2016-08-31
Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters Due to Tip Fracture
Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.
Product
Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2616-2016·2016-08-31
Cook Inc. Recalls Haskal Transjugular Intrahepatic Portal Access Sets
Cook Inc. is recalling Haskal Transjugular Intrahepatic Portal Access Sets due to polymer degradation that can cause catheter tip fracture and separation.
Product
Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2615-2016·2016-08-31
Cook Inc. Recalls FluoroSet Radiographic Tubal Assessment Sets
Cook Inc. is recalling 1,881 FluoroSet Radiographic Tubal Assessment Sets due to polymer degradation that can cause catheter tip fracture or separation.
Product
FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for eva
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2619-2016·2016-08-31
Cook Inc. Recalls Neff DAgostino Percutaneous Access Sets Due to Tip Fracture
Cook Inc. is recalling 5,020 Neff DAgostino Percutaneous Access Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.
Product
Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2611-2016·2016-08-31
Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters
Cook Inc. is recalling 532,395 Beacon Tip Royal Flush Plus High-Flow Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.
Product
Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angio
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2614-2016·2016-08-31
Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Fracture
Cook Inc. is recalling Slip-Cath Beacon Tip Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.
Product
Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2617-2016·2016-08-31
Cook Inc. Recalls Kumpe Access Catheters Due to Tip Fracture Risk
Cook Inc. is recalling 26,076 Kumpe Access Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.
Product
Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2622-2016·2016-08-31
Cook Inc. Recalls Transluminal Biliary Biopsy Forceps Sets Due to Tip Fracture
Cook Inc. is recalling 2,606 Transluminal Biliary Biopsy Forceps Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.
Product
Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2620-2016·2016-08-31
Cook Inc. Recalls Aprima Access Nonvascular Introducer Sets Due to Tip Fracture
Cook Inc. is recalling Aprima Access Nonvascular Introducer Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to medical complications.
Product
Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0917-2015·2015-01-21
Boston Scientific Recalls Lotus TAVR 27mm Transcatheter Aortic Valve Prosthesis
Boston Scientific is recalling 278 units of the Lotus TAVR 27mm valve because the device may unlock during release, potentially causing the valve to embolize.
Product
Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV270, Catalog Number LTV27; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific ao
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0915-2015·2015-01-21
Boston Scientific Recalls Lotus TAVR 23mm Transcatheter Aortic Valve Prosthesis
Boston Scientific is recalling 278 units of the Lotus TAVR 23mm valve because the device may unlock during release, potentially causing the valve to embolize.
Product
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific a
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0916-2015·2015-01-21
Boston Scientific Recalls Lotus TAVR Valve Prosthesis Due to Unlocking Risk
Boston Scientific is recalling Lotus TAVR 25mm valve prostheses because the valve may unlock during release, potentially requiring additional procedures or surgery.
Product
Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV250, Catalog Number LTV25; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific ao
Category
Medical Device
Distribution
0 states