FOGARTY CORKSCREW 140806Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00690103042412), received between Jan 26, 2023 and Nov 10, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K233619, K901625); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Material Fragmentation; Material Fragmentation

  AS REPORTED, DURING USE IN PATIENT, THIS FOGARTY CORKSCREW CATHETER WIRE WAS COILED AND TWISTED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE SPIRAL CABLE WAS EXPOSED THROUGH A TEAR IN THE LATEX MEMBRANE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23508990 ↗
• MalfunctionOct 28, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED DURING USE IN PATIENT THIS FOGARTY CORKSCREW CATHETER COULD NOT BE REMOVED FROM THE SHEATH INTRODUCER WHEN ATTEMPTING TO WITHDRAW THE CATHETER FROM THE PATIENT. AS A RESULT THE CATHETER WAS WITHDRAWN ALONG WITH THE INTRODUCER. HEMOSTASIS WAS ACHIEVED AND NO ADDITIONAL INCISION OR EXTENSION OF HOSPITALIZATION WAS REQUIRED DUE TO THIS ISSUE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408284 ↗
• MalfunctionJan 24, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A WIRE OF THE FOGARTY CORKSCREW CATHETER WAS DETACHED DURING USE. NO FURTHER INFORMATION IS AVAILABLE AT THIS MOMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229613 ↗
• MalfunctionOct 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE MEMBRANE OF THIS 140806 FOGARTY CORKSCREW CATHETER WAS TORN DURING THROMBECTOMY IN THE ARTIFICIAL BLOOD VESSEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359467 ↗
• MalfunctionMay 16, 2024Break; Break

  IT WAS REPORTED THAT THE LATEX MEMBRANE GOT TORN AFTER SEVERAL (3-4 TIMES) ACTUATION DURING USE. NO PATIENT INJURY WAS REPORTED. THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19337284 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT THE MEMBRANE OF THE FOGARTY CORKSCREW CATHETER WAS TORN AND THE WIRE WAS EXPOSED DURING USE. AFTER REPLACING THE CATHETER WITH A DIFFERENT LOT NUMBER, THE CATHETER COULD BE USED WITHOUT ANY PROBLEM. PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNAVAILABLE. THE DEVICES WERE DISCARDED AT THE HOSPITAL DUE TO INFECTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED. WITHOUT RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. HOWEVER, AN INVESTIGATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE LOT NUMBER. PER THE DEVICE HISTORY RECORD REVIEW, THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. SINCE A FAILURE MODE COULD NOT BE CONFIRMED, FURTHER INVESTIGATION COULD NOT BE PERFORMED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060252 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT THE MEMBRANE OF THE FOGARTY CORKSCREW CATHETER WAS TORN AND THE WIRE WAS EXPOSED DURING USE. AFTER REPLACING THE CATHETER WITH A DIFFERENT LOT NUMBER, THE CATHETER COULD BE USED WITHOUT ANY PROBLEM. PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNAVAILABLE. THE DEVICES WERE DISCARDED AT THE HOSPITAL DUE TO INFECTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED. WITHOUT RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. HOWEVER, AN INVESTIGATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE LOT NUMBER. PER THE DEVICE HISTORY RECORD REVIEW, THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. SINCE A FAILURE MODE COULD NOT BE CONFIRMED, FURTHER INVESTIGATION COULD NOT BE PERFORMED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060233 ↗
• MalfunctionJan 26, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT AFTER THE MEMBRANE OF THE FOGARTY CATHETER, MODEL 140806 FROM LOT 64274377, WAS EXPANDED IN THE BODY OF THE PATIENT, THE MEMBRANE BECAME UNABLE TO MOVE EVEN THOUGH THE CONTROL BUTTON WAS ACTUATED. NO ADDITIONAL TREATMENT NOR NEW ACCESS SITE WERE REQUIRED AT THE TIME OF THE CATHETER REMOVAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION REPORTED THAT THE MEMBRANE OF THE CATHETER DID NOT MOVE BACK FROM THE EXPANDED POSITION AND HAD TO BE CUT FROM OUTSIDE OF THE BODY OF THE PATIENT TO BE REMOVED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251241 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K233619, K901625. One submission often covers many models, so check the product and lot details in each record.

• Z-3077-2017 · Jul 6, 2017 · Terminated
  Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripher