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.

1–25 of 69

HighFDA (Devices)·Z-1773-2024·2024-05-15
Vascular catheter recalled for potential metal shavings that may cause embolization
Angiodynamics recalled a vascular access catheter used for hemodialysis because it may contain loosely affixed metal shavings. These shavings could potentially detach and move through blood vessels, possibly requiring surgical removal.
Product
DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028201
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1767-2024·2024-05-15
FDA Recalls Vascular Access Device Due to Loose Metal Shavings Risk
Angiodynamics' DURAMAX STACKED TIP vascular access device may contain loosely affixed metal shavings that could cause blood vessel blockage, potentially requiring surgical removal.
Product
DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028035
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1768-2024·2024-05-15
Hemodialysis vascular access kit recalled due to metal shavings risk
DURAMAX hemodialysis vascular access kits are recalled due to potential metal shavings that could enter the bloodstream and require surgical removal. Thirty units distributed in Virginia are affected.
Product
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028041
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1761-2024·2024-05-15
Vascular access device recalled due to loose metal shavings
DURAFLOW 2 vascular access kits for hemodialysis are being recalled because some units may contain loosely affixed metal shavings that could travel through blood vessels and potentially require surgical removal.
Product
DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012021
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1766-2024·2024-05-15
Medical Device Recall: Angiodynamics DURAMAX Tunneler with Metal Shavings
Angiodynamics is recalling DURAMAX STACKED TIP medical devices that may contain loosely affixed metal shavings with potential to embolize, requiring possible surgical removal. The recall affects 50 units distributed in Virginia.
Product
DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1302-2024·2024-04-03
Boston Scientific steerable sheath devices recalled due to manufacturing defect risk
Boston Scientific is recalling 461 POLARSHEATH Steerable Sheath devices due to a manufacturing tooling error that may cause inner sheath delamination and potential fragment release during medical procedures.
Product
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2217-2023·2023-08-02
Datascope SENSATION 7 Intra-Aortic Balloon Catheters Recalled for Introducer Fracture Risk
The SENSATION 7 Fr. intra-aortic balloon catheter introducer dilator may fracture during insertion, potentially damaging blood vessels and requiring surgery. One death has been reported among 10 total complaints.
Product
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2223-2023·2023-08-02
LINEAR intra-aortic balloon catheter introducer dilator fracture risk
Datascope's LINEAR intra-aortic balloon catheters may develop a fractured introducer dilator that can injure blood vessels or cause dangerous blockages. The company has received 10 complaints including 1 death and 3 serious adverse events.
Product
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number LINEAR 7.5Fr. 34cc IAB WITH ACCES
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2219-2023·2023-08-02
Intra-Aortic Balloon Catheter kits recalled due to dilator fracture risk
Datascope's MEGA 7.5Fr. intra-aortic balloon catheter kits may have introducers that fracture during insertion, risking arterial damage and embolization. The firm has received 10 complaints including 3 serious events and 1 death.
Product
MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH ACCESSOR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2222-2023·2023-08-02
Intra-aortic balloon catheter recall due to introducer dilator fracture risk
Datascope Corp. is recalling SENSATION PLUS 8Fr. intra-aortic balloon catheters because the introducer dilator may fracture during insertion, risking blood vessel damage and surgical intervention. The company received 10 complaints, including 1 death.
Product
SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 8Fr. 50cc I
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2220-2023·2023-08-02
MEGA Intra-Aortic Balloon Catheter Introducer Fracture Poses Arterial Injury Risk
Datascope's MEGA 8Fr. intra-aortic balloon catheter introducer may fracture during insertion, leaving fragments that can damage blood vessels. The firm has reported 10 complaints, including 1 death.
Product
MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK D68
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2218-2023·2023-08-02
Intra-Aortic Balloon Catheter Introducer Dilator May Fracture During Insertion
Datascope TRANS-RAY IAB catheters may have introducer dilators that fracture during insertion, risking arterial damage or blood clots. The firm reports 1 death and 3 serious injuries.
Product
TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR. 4
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2224-2023·2023-08-02
Intra-Aortic Balloon Catheter Introducer Set fracture causes vascular injury
Datascope Corp. recalls Reinforced Introducer Sets because the dilator may fracture during catheter insertion, risking arterial damage and embolization. One patient death has been reported.
Product
REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SE
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2221-2023·2023-08-02
Datascope SENSATION PLUS Intra-Aortic Balloon Catheter Dilator Fracture Risk
Datascope's SENSATION PLUS intra-aortic balloon catheter dilator may fracture during insertion, potentially damaging the femoral artery or aorta. The firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Product
SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 7.5Fr. 40c
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2114-2023·2023-07-26
Abiomed Impella 5.5 pump recalled due to impeller blade damage risk
Abiomed is recalling the Impella 5.5 with SmartAssist pump due to a risk of impeller blade destruction when used with aortic valve replacement devices. Damage can result in low blood flow and systemic embolization, where broken pump pieces may enter the bloodstream.
Product
Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2113-2023·2023-07-26
Impella LD cardiac pump recalled for impeller damage and embolization risk
Abiomed recalls Impella LD blood pumps due to potential interaction with aortic valve replacement devices that can damage the pump impeller and cause blood clots. Patients with these devices should contact their healthcare provider.
Product
Impella LD intravascular micro axial blood pump, Product Number 005082
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2111-2023·2023-07-26
Impella 2.5 blood pump recalled due to impeller blade damage risk
Impella 2.5 intravascular blood pumps may experience unintended interaction with aortic valve replacement stents, damaging impeller blades and reducing blood flow. Fragments may circulate through the bloodstream.
Product
Impella 2.5 intravascular micro axial blood pump, Product Number 005042
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1048-2023·2023-02-08
GORE CARDIOFORM Septal Occluder Recalled for Incomplete Quality Documentation
W L Gore & Associates is recalling 14 units of the GORE CARDIOFORM Septal Occluder (GSX0030A) due to incomplete quality test documentation. The missing verification of device release could pose a potential risk of device failure and serious complications.
Product
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0117-2023·2022-10-26
MitraClip G4 and TriClip G4 Cardiac Devices Recalled for Clip Locking Malfunction
Abbott has recalled MitraClip G4 and TriClip G4 cardiac repair devices due to clip locking malfunctions that may prevent proper device deployment. These malfunctions could lead to failed procedures and serious complications including device embolization.
Product
Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT REPAIR-MR Clinical/CDS0704-XT, MitraClip G4 CDS XTW REPAIR-MR Clinical/CDS0704-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriCli
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0115-2023·2022-10-26
MitraClip Clip Delivery System Recalled for Locking Malfunctions
Abbott Vascular is recalling MitraClip Clip Delivery System devices due to observed increases in clip locking malfunctions that can lead to recurrence of mitral regurgitation, device embolization, or tissue injury.
Product
Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery System NTW US/CDS0701-NTW, MitraClip G4 Clip Delivery System XT US/CDS0701-XT, MitraClip G4 Clip Delivery System XTW US/CDS0701-XTW.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0694-2022·2022-03-16
Medtronic TurboHawk Plus Directional Atherectomy System Recalled Due to Design Defect
ev3 Inc. is recalling the Medtronic TurboHawk Plus Directional Atherectomy System due to design similarities to a device with reported tip detachment and embolization incidents. The FDA has classified this as a Class I recall.
Product
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0695-2022·2022-03-16
Medtronic TurboHawk Plus atherectomy system recalled for potential tip detachment
The Medtronic TurboHawk Plus Directional Atherectomy System (catalog THP-S) is being recalled due to design similarities to another device that experienced tip detachment and embolization. The recall affects 245 devices distributed nationwide.
Product
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0450-2022·2022-01-26
Medtronic HawkOne Atherectomy System Recalled for Tip Detachment and Embolization Risk
Medtronic is recalling the HawkOne Directional Atherectomy System globally due to reports of tip damage that can detach and cause embolization. The device is used to remove arterial plaque in peripheral blood vessels.
Product
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0451-2022·2022-01-26
Medtronic HawkOne Directional Atherectomy Device Recalled for Tip Damage
Medtronic is recalling 28,094 units of its HawkOne directional atherectomy system due to reports of catheter tip damage and detachment that can cause blood clots in blood vessels.
Product
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0394-2022·2021-12-29
WIRION Embolic Protection System Filter Withdrawal Difficulties
Cardiovascular Systems Inc recalls WIRION Embolic Protection System devices (6Fr) because the filter assembly may become difficult to withdraw, and the device may tear or separate, creating a risk of blood clot embolization.
Product
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
Category
Medical Device
Distribution
38 states