FOGARTY 12TLW804FRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00690103043518), received between Jul 13, 2022 and Jan 9, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 reports).

1 other recall cover devices cleared under the same FDA submission (K240078, K892410); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING SET-UP THIS FOGARTY EMBOLECTOMY CATHETER BODY WAS BROKEN IN HALF. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766604 ↗
• MalfunctionNov 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING SET UP, THIS FOGARTY EMBOLECTOMY CATHETER BROKE. NO MORE AVAILABLE INFORMATION. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED. AS PER PRODUCT EVALUATION FINDINGS, CATHETER BODY WAS BROKEN NEXT TO Y-ADAPTER. CROSS SURFACE OF BROKEN SECTION APPEARED UNEVEN AND ROUGH. BROKEN SECTIONS APPEARED TO MATCH UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496983 ↗
• MalfunctionOct 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE CATHETER BODY NEAR THE Y-ADAPTER OF THIS FOGARTY EMBOLECTOMY CATHETER WAS SEPARATED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323535 ↗
• MalfunctionSep 17, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER BURST. THERE IS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION, AS PER PRODUCT INVESTIGATION FINDINGS, BALLOON DID NOT INFLATE DUE TO A RUPTURE AT THE CENTRAL AREA. THE EDGES OF LATEX DID NOT APPEARED TO MATCH AT THE RUPTURE LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074104 ↗
• MalfunctionSep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF THIS FOGARTY CATHETER IN PATIENT; THE CATHETER BODY WAS COMPLETELY DETACHED. NO FURTHER INFORMATION WAS AVAILABLE AT THIS MOMENT. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY OR HARM ASSOCIATED WITH THE REPORTED COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22984255 ↗
• MalfunctionAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED; WHILE TESTING THIS FOGARTY EMBOLECTOMY CATHETER, IT BROKE IN HALF. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737191 ↗
• MalfunctionJul 21, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING TESTING, THIS FOGARTY EMBOLECTOMY CATHETER LEAKED SALINE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. DURING THE EVALUATION, THE BALLOON WAS FOUND TO BE RUPTURED IN THE MIDDLE AREA. THE EDGES OF LATEX DID NOT MATCH AT THE RUPTURED REGION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553841 ↗
• MalfunctionJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT, THIS FOGARTY EMBOLECTOMY CATHETER WAS DETACHED FROM THE BACKFORM. THE BROKEN PART DID NOT REMAINED INSIDE THE PATIENT. THEREFORE, NO ADDITIONAL INTERVENTION WAS NEEDED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184163 ↗
• MalfunctionApr 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING TESTING BEFORE USE IN PATIENT, THIS FOGARTY EMBOLECTOMY CATHETER BROKE IN HALF. THERE WAS NO ALLEGATION OF PATIENT INJURY. THERE WAS NO FURTHER INFORMATION NOR PICTURES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935135 ↗
• MalfunctionApr 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED; WHILE TESTING THIS FOGARTY EMBOLECTOMY CATHETER, IT BROKE INTO TWO PIECES. NO MORE AVAILABLE INFORMATION. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891582 ↗
• MalfunctionJan 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT, THIS FOGARTY EMBOLECTOMY CATHETER SNAPPED (SEE IMAGE PROVIDED). ADDITIONAL INTERVENTION TO REMOVE DETACHED PART FROM INSIDE THE PATIENT NOT REQUIRED. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT AVAILABLE. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21238755 ↗
• MalfunctionDec 4, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, BEFORE PROCEDURE, THE BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER COULD NOT INFLATE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION. THE BALLOON WAS FOUND TO BE RUPTURED IN THE CENTRAL AREA AND THE EDGES OF LATEX DID NOT MATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20841045 ↗
• MalfunctionAug 22, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF THE FOGARTY CATHETER WAS FOUND TO BE RUPTURED DURING DEVICE PREPARATION BEFORE USE IN THE PATIENT. PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20029487 ↗
• MalfunctionAug 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT, THIS FOGARTY EMBOLECTOMY CATHETER GUIDEWIRE DID NOT PASS THROUGH THE CATHETER, DESPITE HAVING THE RIGHT SIZE. THERE WAS NO ALLEGATION OF PATIENT INJURY. AS PER DEVICE EVALUATION RESULTS, THE CATHETER BODY WAS FOUND BROKEN INTO TWO PIECES. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20010965 ↗
• MalfunctionJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT. WITH THIS FOGARTY EMBOLECTOMY CATHETER BROKE INTO TWO PIECES. NO ADDITIONAL INTERVENTION WAS NEEDED. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHIC INFORMATION UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806030 ↗
• MalfunctionJul 12, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING USE IN PATIENT WHILE TESTING THIS FOGARTY EMBOLECTOMY CATHETER, THE BALLOON BURST. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE BALLOON WAS FOUND TO BE RUPTURED IN THE MIDDLE AREA, THE EDGES OF LATEX DID NOT MATCH AT THE RUPTURED REGION. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727910 ↗
• MalfunctionJul 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING PROCEDURE, THIS FOGARTY EMBOLECTOMY CATHETER BROKE DUE TO PREVIOUS GUIDEWIRE BREAKAGE. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHIC INFORMATION UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727891 ↗
• MalfunctionApr 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE, THE BALLOON OF THIS FOGARTY CATHETER RUPTURED. THERE WAS NO PROBLEM FOUND DURING THE BALLOON INFLATION TEST. THE BALLOON RUPTURED SOON AFTER INSERTING INTO THE PATIENT. THERE WAS NO CALCIFICATION OBSERVED. THE PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. OUR PRODUCT LAB RECEIVED ONE MODEL 12TLW804F CATHETER. THE REPORTED ISSUE OF THE BALLOON RUPTURE WAS CONFIRMED. BOTH DISTAL AND PROXIMAL RUPTURED EDGES WERE INVERTED TO THE OTHER SIDE. AFTER BOTH RUPTURED EDGES WERE RETURNED TO ORIGINAL POSITION AND PROXIMAL WINDINGS WAS CUT, THE RUPTURED EDGES DID NOT APPEAR TO MATCH UP. PER THE IFU, BALLOON RUPTURE AND CATHETER SEPARATION AS A RESULT OF EXCESSIVE PULL FORCE APPLIED TO REMOVE ADHERENT MATERIAL ARE THE MOST FREQUENT CAUSES OF REPORTED FAILURES. AND TO MINIMIZE THE RISK OF VESSEL DAMAGE, BALLOON RUPTURE, OR TIP DETACHMENT, DO NOT EXCEED THE MAXIMUM RECOMMENDED INFLATION VOLUME AND PULL FORCE FOR EACH SIZE CATHETER. THERE WAS NO VISIBLE DAMAGE OR INCONSISTENCY OBSERVED FROM THE CATHETER BODY AND WINDINGS. THRU-LUMEN WAS PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. A DEVICE HISTORY RECORD REVIEW WAS COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19041720 ↗
• MalfunctionFeb 28, 2023Break; Break

  IT WAS REPORTED THAT DURING A CASE, A 12TLW804F FOGARTY CATHETER FROM LOT 64664590, BROKE OFF INTO A PATIENT WHILE DOING A DE-CLOT PROCEDURE. THE BALLOON NEEDED TO BE SNARED TO REMOVE IT FROM THE GRAFT OF THE PATIENT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Foreign Body Embolism

  MAUDE report 16454530 ↗
• MalfunctionJul 13, 2022Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED THAT BEFORE USE, THE BALLOON WOULD NOT INFLATE DURING THE INFLATION TEST. THE DEVICE WAS REPLACED, AND THE PROBLEM WAS SOLVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PRODUCT WAS RETURNED FOR EVALUATION. THE BALLOON LATEX APPEARED DISCOLORED AND DETERIORATED. THE EDGES OF THE HOLES AND CRACKS DID NOT APPEAR TO MATCH UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008354 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K240078, K892410. One submission often covers many models, so check the product and lot details in each record.

• Z-0238-2024 · Sep 7, 2023 · Open, Classified
  Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35