FOGARTY 12TLW805F35Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00690103043532), received between Oct 5, 2021 and Aug 7, 2026 — classified as 1 injury, 43 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (11 reports).

1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 2, 2026Material Fragmentation

  AS REPORTED, DURING USE IN PATIENT, THE BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS PER PRODUCT EVALUATION, THE BALLOON WAS FOUND TO BE RUPTURED AT CENTRAL AREA AND THE RUPTURED EDGES DID NOT APPEARED TO MATCH. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23941627 ↗
• MalfunctionDec 11, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT BEFORE USE OF THE FOGARTY CATHETER, WHEN BENCH TESTING, IT WOULD EITHER NOT INFLATE OR WAS DIFFICULT TO INFLATE AND THEN NOT DEFLATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785827 ↗
• MalfunctionDec 11, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DURING USE OF THE FOGARTY CATHETER IT WOULD EITHER NOT INFLATE OR WAS DIFFICULT TO INFLATE AND THEN NOT DEFLATE. THE CATHETER WAS REMOVED FROM THE PATIENT ONCE THE ISSUE WAS NOTICED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785791 ↗
• 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 23766725 ↗
• MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, BEFORE USING THIS FOGARTY EMBOLECTOMY CATHETER, THE CATHETER WAS BROKEN INTO TWO PIECES. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750655 ↗
• MalfunctionNov 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT, THE BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER FAILED THE INFLATION. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE CATHETER BODY WAS BROKEN INTO TWO PIECES. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494701 ↗
• MalfunctionOct 20, 2025Degraded; Material Fragmentation; Degraded; Material Fragmentation

  AS REPORTED, DURING USE IN PATIENT OF THIS FOGARTY CATHETER, THE BALLOON DID NOT INFLATE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION. AS PER PRODUCT EVALUATION RESULTS, MULTIPLE CRACKS WERE EVIDENT ON THE BALLOON LATEX AND CRACKS DID NOT APPEAR TO MATCH AT THE RUPTURED LOCATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23344241 ↗
• MalfunctionOct 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, BEFORE USE IN PATIENT, THIS FOGARTY EMBOLECTOMY CATHETER BROKE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS PER EVALUATION FINDINGS, THE CATHETER BODY WAS FOUND SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323977 ↗
• MalfunctionSep 12, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING USE AFTER SUCCESSFUL TESTING OF THIS FOGARTY EMBOLECTOMY CATHETER, BALLOON BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION. AS PER EVALUATION RESULTS, 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 23035189 ↗
• InjurySep 9, 2025Material Fragmentation; Material Fragmentation

  AS REPORTED, DURING THE TEST OF THIS FOGARTY EMBOLECTOMY CATHETER, THE BALLOON BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED. AS PER EVALUATION FINDINGS, THE BALLOON WAS FOUND TO BE RUPTURED AT THE CENTRAL AREA. BALLOON EDGES DID NOT APPEAR TO MATCH AT THE RUPTURED REGION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23002022 ↗
• MalfunctionSep 9, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING USE OF THIS FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER, BALLOON BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION. AS PER EVALUATION RESULTS, BALLOON WAS FOUND TO BE RUPTURED IN THE CENTRAL AREA. THE BALLOON EDGES DID NOT APPEAR TO MATCH AT THE RUPTURED REGION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001850 ↗
• MalfunctionAug 5, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING TESTING OF THIS FOGARTY EMBOLECTOMY CATHETER A SALINE LEAKAGE WAS NOTICED. NO FURTHER INFORMATION AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS NOT AVAILABLE. AS PER PRODUCT EVALUATION, THE BALLOON WAS FOUND TO BE RUPTURED AT CENTRAL AREA AND THE RUPTURED EDGES DID NOT APPEARED TO MATCH AT THE RUPTURED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715130 ↗
• MalfunctionJul 31, 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. A PER PRODUCT EVALUATION FINDINGS, THE BALLOON WAS FOUND TO BE RUPTURED IN THE CENTRAL AREA. THE RUPTURED EDGES DID NOT APPEAR TO MATCH UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673724 ↗
• MalfunctionJul 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT BEFORE USE OF THIS FOGARTY CATHETER, THE BALLOON WAS BROKEN. THE BALLOON DID NOT INFLATE WHEN TESTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569912 ↗
• MalfunctionJul 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT BEFORE USE OF THIS FOGARTY CATHETER, THE BALLOON WAS BROKEN. THE BALLOON DID NOT INFLATE WHEN TESTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569891 ↗
• MalfunctionJul 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT BEFORE USE OF THIS FOGARTY CATHETER, THE BALLOON WAS BROKEN. THE BALLOON DID NOT INFLATE WHEN TESTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569521 ↗
• MalfunctionJul 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT BEFORE USE OF THIS FOGARTY CATHETER, THE BALLOON WAS BROKEN. THE BALLOON DID NOT INFLATE WHEN TESTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569402 ↗
• MalfunctionJul 22, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, WHILE TESTING THIS FOGARTY EMBOLECTOMY CATHETER, THE BALLOON BURST. 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. THE RUPTURED EDGES DID NOT APPEARED TO MATCH AT THE RUPTURED LOCATION. PATIENT DEMOGRAPHIC DATA UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563494 ↗
• MalfunctionJul 17, 2025Failure to Deflate; Failure to Deflate

  AS REPORTED, WHEN TESTING THE BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER, IT WORKED CORRECTLY, HOWEVER, DURING USE, THE BALLOON WAS DIFFICULT TO DEFLATE. AS PER PRODUCT EVALUATION FINDINGS, THE PROXIMAL BUSHING AND WINDINGS HAD SLIPPED DISTAL ON THE CATHETER TIP. PROXIMAL WINDINGS WERE LOCATED ON THE BALLOON INFLATION PORT. ADHESIVE WAS VISIBLE AT THE BOND LOCATION ON THE CATHETER TIP. BALLOON WAS UNABLE TO BE DEFLATED AS IT WAS SLIPPED DISTAL OF THE INFLATION PORTS. THERE IS NO ALLEGATION OF PATIENT INJURY. THERE IS NO MORE AVAILABLE INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530347 ↗
• MalfunctionJun 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT BEFORE USE OF THIS FOGARTY CATHETER, THE BALLOON WAS BROKEN. THE BALLOON DID NOT INFLATE WHEN TESTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367124 ↗