FOGARTYRecalls & reported problems across all models
Edwards Lifesciences LLC · 32 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one FOGARTY model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 486
- Deaths reported
- 1
- Injuries reported
- 12
- Recalls
- 3
We found 32 models of FOGARTY by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 486 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2019 and Aug 26, 2026 — classified as 1 death, 12 injuries, 473 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (258 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
FOGARTY recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 7, 2023Open, Classified
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Z-0238-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Oct 6, 2022Open, Classified
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
Z-0147-2023 · Root cause: Packaging · names 3 of these models · Recall details · FDA record ↗
- Oct 6, 2022Open, Classified
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
Z-0146-2023 · Root cause: Packaging · names 10 of these models · Recall details · FDA record ↗
Most reported FOGARTY problems
Device problems
- Material Fragmentation258
- Burst Container or Vessel51
- Detachment of Device or Device Component48
- Material Disintegration28
- Material Rupture23
- Degraded20
- Material Puncture/Hole16
- Failure to Deflate15
Patient problems
- No Clinical Signs, Symptoms or Conditions459
- Foreign Body In Patient13
- Foreign Body Embolism5
- Insufficient Information3
- No Known Impact Or Consequence To Patient3
- Embolism/Embolus2
- Device Embedded In Tissue or Plaque1
- Hemorrhage/Blood Loss/Bleeding1
FOGARTY models
32 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Fogarty 120804FPCatheter, Embolectomy1 recall1 death200 reports
- FOGARTY 120404FPCatheter, Embolectomy1 recall61 reports
- Fogarty 120805FPCatheter, Embolectomy1 recall45 reports
- FOGARTY 12TLW805F35CATHETER, EMBOLECTOMY1 recall44 reports
- Fogarty 120803FPCatheter, Embolectomy1 recall3 reports
- Fogarty 120602FPCatheter, Embolectomy1 recall3 reports
- Fogarty 120806FPCatheter, Embolectomy1 recall2 reports
- FOGARTY 120403FPCatheter, Embolectomy1 recall1 report
- Fogarty 120807FPCatheter, Embolectomy1 recall0 reports
- FOGARTY 410235FPBiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection1 recall0 reports
- FOGARTY 410236FPBiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection1 recall0 reports
- FOGARTY 410405FPBiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection1 recall0 reports
- FOGARTY 120403FSPCatheter, Embolectomy1 recall0 reports
- Fogarty 120803FSPCatheter, Embolectomy1 recall0 reports
- FOGARTY 12TLW405F35CATHETER, EMBOLECTOMY25 reports
- FOGARTY 12TLW804FCATHETER, EMBOLECTOMY22 reports
- FOGARTY 12TLW803FCATHETER, EMBOLECTOMY19 reports
- FOGARTY 120602FCATHETER, EMBOLECTOMY15 reports
- FOGARTY 120403FCATHETER, EMBOLECTOMY9 reports
- FOGARTY 120804FCATHETER, EMBOLECTOMY7 reports
- FOGARTY 120803FCATHETER, EMBOLECTOMY5 reports
- FOGARTY 12TLW806FCATHETER, EMBOLECTOMY5 reports
- FOGARTY 12TLW403FCATHETER, EMBOLECTOMY4 reports
- FOGARTY 120404FCATHETER, EMBOLECTOMY3 reports
- FOGARTY 12TLW404FCATHETER, EMBOLECTOMY3 reports
- FOGARTY 12TLW807FCATHETER, EMBOLECTOMY3 reports
- FOGARTY 120805FCATHETER, EMBOLECTOMY2 reports
- FOGARTY 120803FSCATHETER, EMBOLECTOMY1 report
- FOGARTY 220804FCATHETER, IRRIGATION1 report
- FOGARTY 620404FCatheter, intravascular occluding, temporary1 report
- FOGARTY 62080814FCatheter, intravascular occluding, temporary1 report
- FOGARTY 12TLW1203FCATHETER, EMBOLECTOMY1 report
Recent FOGARTY adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Failure to Deflate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50454702 ↗MalfunctionAug 7, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50170612 ↗MalfunctionMay 22, 2026Material Fragmentation
AS REPORTED, DURING USE IN PATIENT, THE BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER BURST. THERE IS NO ALLEGATION OF MISSING PIECES. NO ADDITIONAL INTERVENTION WAS REQUIRED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE BALLOON EDGES DID NOT MATCH AT THE RUPTURED REGION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25252216 ↗MalfunctionApr 19, 2026Material Fragmentation
AS REPORTED, THE BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER WAS RUPTURED (SEE PICTURE ATTACHED). THERE IS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS PER PRODUCT EVALUATION FINDINGS, BALLOON WAS FOUND TO BE RUPTURED LONGITUDINALLY. BALLOON EDGES DID NOT APPEAR TO MATCH AT THE RUPTURED REGION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24921271 ↗MalfunctionApr 17, 2026Material Fragmentation
AS REPORTED, DURING PREOPERATIVE TESTING OF THIS FOGARTY EMBOLECTOMY CATHETER, THE BALLOON WAS FOUND TO BE RUPTURED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE BALLOON WAS FOUND COMPLETELY BROKEN IN THE MIDDLE AREA; THE LATEX EDGES AT THE RUPTURE SITE DID NOT MATCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24908018 ↗MalfunctionApr 15, 2026Burst Container or Vessel
AS REPORTED, DURING USE IN A PATIENT FOR THE REMOVAL OF AN INTRAVASCULAR THROMBUS AND EMBOLI, THE FRONT-END BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER RUPTURED AND COULD NOT BE INFLATED. AS PER CUSTOMER'S OPINION THIS MIGHT CAUSED AN INTERRUPTION DURING SURGERY AND INCREASED SURGICAL RISK. THE DEVICE WAS IMMEDIATELY DISCONTINUED, AND ANOTHER CATHETER WAS USED, FUNCTIONING NORMALLY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24881411 ↗MalfunctionMar 18, 2026Deflation Problem
AS REPORTED DURING USE THE FOGARTY CATHETER BALLOON DID NOT DEFLATE. THE CLINICIAN TRIED TO DEFLATE THE BALLOON MULTIPLE TIMES USING THE SYRINGE THAT COMES WITH THE DEVICE AND ADDITIONAL SYRINGES ON THE FIELD BUT THE ISSUE WAS NOT RESOLVED. EVENTUALLY, THEY HAD TO PULL THE DEVICE BACK INTO THE SHEATH AS FAR AS THEY COULD WHICH CAUSED THE BALLOON TO POP. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION PER THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24631378 ↗MalfunctionMar 18, 2026Deflation Problem
AS REPORTED DURING USE THE FOGARTY CATHETER BALLOON DID NOT DEFLATE. THE CLINICIAN TRIED TO DEFLATE THE BALLOON MULTIPLE TIMES USING THE SYRINGE THAT COMES WITH THE DEVICE AND ADDITIONAL SYRINGES ON THE FIELD BUT THE ISSUE WAS NOT RESOLVED. EVENTUALLY, THEY HAD TO PULL THE DEVICE BACK INTO THE SHEATH AS FAR AS THEY COULD WHICH CAUSED THE BALLOON TO POP. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION PER THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24631158 ↗MalfunctionFeb 4, 2026Failure to Deflate
AS REPORTED, DURING DEVICE PREP, THE BALLOON OF A FOGARTY THRU-LUMEN CATHETER COULD NOT BE DEFLATED. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24264181 ↗MalfunctionJan 30, 2026Material Fragmentation; Inflation Problem
AS REPORTED, DURING USE IN A PATIENT WITH THIS FOGARTY EMBOLECTOMY CATHETER, THE BALLOON INFLATION FAILED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION. AS PER EVALUATION RESULTS, THE BALLOON WAS FOUND TO BE RUPTURED AT CENTRAL AREA. BALLOON EDGES DID NOT APPEAR TO MATCH AT THE RUPTURED REGION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24228901 ↗MalfunctionJan 29, 2026Burst Container or Vessel; Material Fragmentation
AS REPORTED, RIGHT AFTER INSERTION, THE BALLOON OF THIS EMBOLECTOMY FOGARTY CATHETER BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS PER EVALUATION RESULTS, THE BALLOON WAS FOUND TO BE RUPTURED AT CENTRAL AREA. BALLOON EDGES DID NOT APPEAR TO MATCH AT THE RUPTURED REGION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24208394 ↗MalfunctionJan 9, 2026Material Fragmentation
AS REPORTED, DURING SURGERY, THE BALLOON OF THIS EMBOLECTOMY FOGARTY CATHETER LOST PRESSURE SUDDENLY. UPON REMOVAL, THE BALLOON WAS FOUND TO BE RUPTURED. THE ISSUE WAS SOLVED BY REPLACING THE DEVICE WITH A NEW ONE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS PER EVALUATION RESULTS, THE BALLOON WAS FOUND TO BE RUPTURED AT CENTRAL AREA. LATEX EDGES DID NOT APPEAR TO MATCH AT THE RUPTURED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24018788 ↗MalfunctionJan 9, 2026Material Fragmentation
AS REPORTED, THE BALLOON OF THIS EMBOLECTOMY FOGARTY CATHETER WAS BROKEN AND IT COULD NOT BE INFLATED. SEE PICTURE ATTACHED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS PER PRODUCT EVALUATION, MULTIPLE CRACKS AND A TEAR WERE EVIDENT ON BALLOON LATEX. THE EDGES APPEARED TO MATCH UP AT THE TEAR; HOWEVER DISTAL EDGES OF BALLOON DID NOT APPEAR TO MATCH. DISTAL WINDINGS WERE SLIPPED AND NOT RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24018548 ↗MalfunctionJan 8, 2026Detachment of Device or Device Component
AS REPORTED, DURING SURGERY, THE BALLOON OF THIS EMBOLECTOMY CATHETER RUPTURED (SEE PICTURE ATTACHED). THERE IS NO ALLEGATION OF PATIENT INJURY. AS PER PRODUCT EVALUATION FINDINGS, CATHETER BODY TUBE WAS COMPLETELY BROKEN OFF FROM THE DISTAL END OF THE "Y" FITTING. THE CROSS SURFACES OF BROKEN TUBE WERE ROUGH AND UNEVEN. THE EDGES OF THE BROKEN SECTION APPEARED TO MATCH AT THE BREAK SITE. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24015182 ↗MalfunctionJan 2, 2026Material Fragmentation
AS REPORTED, BEFORE USE IN PATIENT, THIS FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER HAD A BALLOON LEAKAGE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION. AS PER EVALUATION RESULTS, THE BALLOON WAS FOUND TO BE RUPTURED IN THE MIDDLE AREA. THE EDGES OF LATEX DID NOT APPEAR TO MATCH AT THE RUPTURED REGION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23943537 ↗
Other Edwards Lifesciences LLC products
- Edwards SAPIEN 315 models · 6,905 reports · 1 recall
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)4 models · 2,986 reports · 1 recall
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve3 models · 2,147 reports
- INSPIRIS RESILIA AORTIC VALVE6 models · 1,305 reports
- EDWARDS ESHEATH INTRODUCER SET4 models · 973 reports
- SAPIEN 3 Ultra RESILIA4 models · 881 reports
- SAPIEN 3 Ultra System3 models · 876 reports
- EDWARDS COMMANDER DELIVERY SYSTEM4 models · 261 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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