The Recall Desk

Hazard

Embolism recalls

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

What the numbers show

Total
55
Critical
3
Severe
31
Most recent
2026-07-08

Of the 55 embolism recalls we have scored against our rubric, 3 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 31 (56%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all embolism 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.

26–50 of 55

  • SevereFDA (Devices)·Z-2377-2023·2023-08-23

    Acute Dialysis Catheters Recalled for Catheter Tip Occlusion

    Covidien recalls 519 MAHURKAR acute dialysis catheters (Lot 2200400292) due to excessive silicone lubricant coating the catheter tip that may cause partial or full occlusion and treatment delays.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2382-2023·2023-08-23

    Mahurkar Dialysis Catheter Center Lumen Occlusion, FDA Class I Recall

    Covidien's Mahurkar dialysis catheters are recalled due to center lumen occlusion from excessive silicone lubricant, risking treatment delay and serious vascular complications.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2386-2023·2023-08-23

    MAHURKAR dialysis catheters recalled for center lumen occlusion risk

    Covidien LP recalls MAHURKAR dialysis catheters due to excessive silicone lubricant on the catheter tip, which can obstruct the center lumen. This may delay treatment and cause serious blood complications including embolism and thrombosis.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2368-2023·2023-08-23

    Dialysis Catheter Recalled Due to Excessive Lubricant Causing Center Lumen Obstruction

    Covidien is recalling MAHURKAR dialysis catheters due to excessive silicone-based lubricant coating the center lumen tip, which may cause partial or complete obstruction, delaying treatment or causing thrombosis.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2385-2023·2023-08-23

    Acute Dialysis Catheter Recalled for Potential Lumen Obstruction and Embolism Risk

    Covidien is recalling MAHURKAR acute dialysis catheters for excessive silicone lubricant causing lumen obstruction that may delay treatment and lead to hemolysis, embolism, or thrombosis.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2370-2023·2023-08-23

    Dialysis catheter recalled due to potential tip occlusion risk

    Covidien is recalling MAHURKAR dialysis catheters that may have excessive lubricant in the catheter tip, potentially causing obstruction. This could delay treatment or cause serious blood complications including thrombosis or embolism.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2375-2023·2023-08-23

    Dialysis catheter recalled due to excessive lubricant causing obstruction

    Covidien's MAHURKAR dialysis catheter is recalled because excessive silicone lubricant can block the center lumen, preventing or reducing blood flow during dialysis. This Class I recall affects 271 units and carries risk of treatment delays, hemolysis, and blood clots.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 8888103004HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2216-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Dilator Fracture During Insertion

    The YAMATO PLUS intra-aortic balloon catheter's introducer dilator may fracture during insertion, risking arterial damage, aortic damage, or blood clots. Datascope has received 10 complaints, including 1 death and 3 serious adverse events.

    Product
    YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description Part Number YAMATO PLUS-R 30cc IAB WITH ACCESSORIE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1077-2022·2022-05-25

    FDA Recalls iCast Covered Stent System Due to Device Separation During Delivery

    Atrium Medical is recalling the iCast Covered Stent System because the balloon or catheter hub may separate from the delivery catheter during use, potentially causing blood clots, vessel blockages, or organ damage.

    Product
    iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 85413 85414 85415 85416 85417 85418 85419 85420 85424 85440 85441 85442 85443 85444 85445 85450 85451 85452 85453
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1076-2022·2022-05-25

    Atrium Advanta V12 Covered Stent System Recalled for Delivery Catheter Separation

    Atrium Medical is recalling the Advanta V12 Covered Stent System worldwide for potential separation of the balloon or catheter hub during withdrawal, which may cause procedural delays and serious complications including embolism and organ infarction.

    Product
    Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1003-2022·2022-05-04

    SpaceOAR Vue System Recalled for Embolism Risk from Misplacement

    The SpaceOAR Vue System implant used in prostate cancer radiotherapy is being recalled because improper hydrogel placement can cause embolism. Boston Scientific has updated instructions and warnings to prevent misplacement.

    Product
    SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1016-2022·2022-05-04

    Empower Introducer Sheath Recalled for Defective Glue and Embolism Risk

    Freudenberg Medical is recalling the Empower Introducer Sheath due to defective adhesive on the catheter shaft that could cause blood clots and tissue damage.

    Product
    Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1002-2022·2022-05-04

    Boston Scientific SpaceOAR System Embolism Risk from Hydrogel Misplacement

    FDA recalls Boston Scientific's SpaceOAR System due to risk of embolism from incorrect hydrogel placement during prostate cancer radiotherapy. Updated instructions provide verification steps for proper placement.

    Product
    SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2022·2022-05-04

    Empower Introducer Sheath recalled for potential embolism and ischemia risk

    Freudenberg Medical is recalling Empower Introducer Sheath devices (Model 668782-200) due to potential adhesive residue inside the catheter shaft that may cause blood clots and tissue damage. Affected devices were distributed in the US and Netherlands.

    Product
    Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0557-2022·2022-02-09

    Chameleon PTA Balloon Catheter difficult protector sleeve removal risk

    The Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm has a protector sleeve that may be difficult to remove, potentially damaging the balloon and causing patient harm. Covidien is recalling 1,994 devices.

    Product
    Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1287-2021·2021-03-31

    Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheath

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.

    Product
    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and a
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1286-2021·2021-03-31

    Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheaths

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.

    Product
    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ab
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1285-2021·2021-03-31

    Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheaths

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.

    Product
    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ab
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1956-2020·2020-05-20

    Merit Medical Recalls Custom Sheath Introducer Kits Due to Labeling Error

    Merit Medical Systems is recalling 15 Custom Sheath Introducer Kits because they were incorrectly labeled and contained the wrong sheath assembly.

    Product
    Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1900-2020·2020-05-13

    Howmedica Recalls Cortoss Bone Augmentation Material Due to Temperature Violations

    Howmedica Osteonics Corp. is recalling 115 units of Cortoss Bone Augmentation Material because shipments were transported outside required refrigerated temperature conditions.

    Product
    Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
    Category
    Medical Device
    Distribution
    15 states
  • SevereFDA (Devices)·Z-0647-2017·2016-12-14

    Centurion Multi-Med Single Lumen Catheters Recalled for Embolism Risk

    Centurion Medical Products is recalling 1,000 Multi-Med Single Lumen Catheter kits because excess material at the catheter tip may separate and cause an embolism.

    Product
    Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0801-2016·2016-03-02

    Cook Inc. Recalls Femoral Artery Pressure Monitoring Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling specific femoral artery pressure monitoring catheter sets and trays because a manufacturing defect may cause the catheter tip to fracture or separate.

    Product
    Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0800-2016·2016-03-02

    Cook Inc. Recalls Single Lumen Pressure Monitoring Sets Due to Tip Fracture

    Cook Inc. is recalling 2,280 single-lumen pressure monitoring sets and trays because a manufacturing defect may cause catheter tips to fracture or separate.

    Product
    Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0799-2016·2016-03-02

    Cook Inc. Recalls Single Lumen Central Venous Catheter Sets

    Cook Inc. is recalling 1,341 single-lumen central venous catheter sets and trays due to a manufacturing defect that may cause catheter tip fracture or separation.

    Product
    Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0802-2016·2016-03-02

    Cook Inc. Recalls Radial Artery Pressure Monitoring Catheter Sets

    Cook Inc. is recalling radial artery pressure monitoring catheter sets because a manufacturing defect may cause the catheter tip to fracture or separate.

    Product
    Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide