FOGARTY 120602FRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00690103043273), received between Oct 18, 2021 and Oct 20, 2025 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF THE EMBOLECTOMY CATHETER, THE TIP BECAME SEPARATED. THE ISSUE OCCURRED WHEN ATTEMPTING TO PASS THE EMBOLECTOMY CATHETER DISTALLY IN THE ULNAR, AND THE USER WAS MET WITH SIGNIFICANT RESISTANCE PULLING BACK. THE PATIENT REQUIRED A CUT DOWN OF THE ULNAR ARTERY TO RETRIEVE THE TIP OF THE CATHETER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335993 ↗
• MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF THE EMBOLECTOMY CATHETER, THE TIP BECAME SEPARATED. THE ISSUE OCCURRED WHEN ATTEMPTING TO PASS THE EMBOLECTOMY CATHETER DISTALLY IN THE ULNAR, AND THE USER WAS MET WITH SIGNIFICANT RESISTANCE PULLING BACK. THE PATIENT REQUIRED A CUT DOWN OF THE ULNAR ARTERY TO RETRIEVE THE TIP OF THE CATHETER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335991 ↗
• MalfunctionAug 5, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING PROCEDURE, THE BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE BALLOON WAS FOUND TO BE RUPTURED WITH FLAP, LEAVING THE WIRES EXPOSED. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22711782 ↗
• MalfunctionApr 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT, THIS FOGARTY ARTERIAL EMBOLECTOMY CATHETER BROKE. THE WIRE WAS EXTRACTED WITH A LOT OF FORCE, HOWEVER A SMALL PIECE STILL STUCK IN THE LOWER LEG. ADDITIONAL SURGERY WAS NOT NEEDED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21934352 ↗
• MalfunctionFeb 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN EMERGENCY THROMBECTOMY ON THE LEFT LOWER EXTREMITY, THE BALLOON BROKE ON THE 2FR FOGARTY THROMBECTOMY CATHETER. THE SCRUB TECH TESTED THE CATHETER BALLOON WITH THE APPROPRIATE AMOUNT OF FLUID BEFORE HANDING TO THE SURGEON TO USE. IN THE PHYSICIAN'S ATTEMPT TO PERFORM THE THROMBECTOMY, AS THEY INFLATED THE BALLOON AND ATTEMPTED TO REMOVE IT FROM PATIENT'S EXTREMITY, THE BALLOON OF THE CATHETER DETACHED AND REMAINS STUCK INSIDE THE PATIENT. PER THE CUSTOMER, THIS OCCURRED TWICE DURING THE CASE. THERE WAS NO ALLEGATION OF PATIENT INJURY. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE HOWEVER NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DEVICE IS EXPECTED TO RETURN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21380603 ↗
• MalfunctionFeb 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN EMERGENCY THROMBECTOMY ON THE LEFT LOWER EXTREMITY THE PHYSICIAN REQUESTED A SIZE 2FR FOGARTY THROMBECTOMY CATHETER. THE SCRUB TECH TESTED THE CATHETER BALLOON WITH THE APPROPRIATE AMOUNT OF FLUID BEFORE HANDING TO THE SURGEON TO USE. IN THE PHYSICIAN'S ATTEMPT TO PERFORM THE THROMBECTOMY, AS THEY INFLATED THE BALLOON AND ATTEMPTED TO REMOVE IT FROM PATIENT'S EXTREMITY, THE BALLOON OF THE CATHETER DETACHED AND REMAINS STUCK INSIDE THE PATIENT. THERE WAS NO ALLEGATION OF PATIENT INJURY. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE HOWEVER NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DEVICE IS EXPECTED TO RETURN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21329054 ↗
• InjuryJan 28, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT OF THIS FOGARTY CATHETER, THE BALLOON GOT STUCK AND DETACHED BEING NOT VISIBLE ANYMORE AT POPLITEAL LEVEL, REMAINING IN THE VESSEL (REPORT NO 2015691-2025-00498). A NEW DEVICE WAS USED AND THE SAME ISSUE OCCURRED (REPORT NO 2015691-2025-00499). BALLOONS WERE ABLE TO BE REMOVED FROM PATIENT, HOWEVER NOT ALL THE BALLOON MATERIAL COULD BE TOTALLY WITHDRAWN. PROCEDURE TO REMOVE BALLOONS IS NOT KNOWN. THE DEVICE WAS RECEIVED FOR EVALUATION. THE BALLOON WAS FOUND TO BE RUPTURED AT THE CENTRAL AREA. RUPTURE EDGES DID NOT APPEAR TO MATCH UP.

  Patient problems: Embolism/Embolus

  MAUDE report 21250982 ↗
• InjuryJan 28, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT OF THIS FOGARTY CATHETER, THE BALLOON GOT STUCK AND DETACHED BEING NOT VISIBLE ANYMORE AT POPLITEAL LEVEL, REMAINING IN THE VESSEL (REPORT NO 2015691-2025-00498). A NEW DEVICE WAS USED AND THE SAME ISSUE OCCURRED (REPORT NO 2015691-2025-00499). BALLOONS WERE ABLE TO BE REMOVED FROM PATIENT, HOWEVER NOT ALL THE BALLOON MATERIAL COULD BE TOTALLY WITHDRAWN. PROCEDURE TO REMOVE BALLOONS IS NOT KNOWN. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: Embolism/Embolus

  MAUDE report 21250949 ↗
• MalfunctionNov 27, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE DR. WAS USING THE 120602F FOGARTY CATHETER AND THE BALLOON POPPED. THE WIRE GOT STUCK IN THE ARTERY. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20794218 ↗
• MalfunctionNov 7, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON OF THIS FOGARTY CATHETER DID NOT DEFLATE AT THE TIME OF THE CATHETER REMOVAL. HOWEVER, IT WAS UNABLE TO CONFIRM WHETHER THE BALLOON FINALLY DEFLATED OR ANY ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT DEMOGRAPHICS WERE REQUESTED BUT NOT AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632710 ↗
• MalfunctionNov 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BALLOON OF A 120602F CATHETER POPPED DURING A THROMBECTOMY SURGERY. THE WIRE THEN GOT STUCK IN THE ARTERY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622506 ↗
• MalfunctionAug 14, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT A FOGARTY CATHETER MALFUNCTIONED WHILE INSIDE THE MAMMARY ARTERY. CATHETER BALLOON WOULD NOT DEFLATE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986115 ↗
• MalfunctionAug 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 120602F FOGARTY CATHETER BALLOON TIP BROKE OFF WHEN PULLING IT OUT OF THE LEG. THE BALLOON REMAINED INFLATED WHEN TAKING THE CLOT OUT. THE TIP BROKE OFF, EXPOSING THE INNER WIRE. THERE WAS NO PATIENT INJURY, AND NO ADDITIONAL PROCEDURES OR IMAGING WAS REQUIRED DUE TO THE PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557187 ↗
• InjuryMay 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE DISTAL END OF A 120602F FOGARTY CATHETER FROM LOT 64703419 BECAME DETACHED FROM PRODUCT WHILE BEING USED. THIS LEFT A PART OF THE PRODUCT LODGED IN THE ARTERY OF THE PATIENT. ANOTHER DOCTOR WAS NEEDED TO ASSIST IN REMOVING THE DETACHED PRODUCT FROM THE ARTERY. ANGIOGRAPHY WAS PERFORMED TO SEE THE PRODUCT LOCATION IN THE ARTERY AND CONFIRMED THAT THE ENTIRE PRODUCT WAS REMOVED. A SECOND INCISION WAS MADE TO SEE IF THE DEFECTIVE PRODUCT COULD BE REMOVED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16992346 ↗
• InjuryOct 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE PERFORMING A THROMBECTOMY PROCEDURE ON THE LEFT LOWER EXTREMITY USING A 2F X 60CM EMBOLECTOMY CATHETER, THE BALLOON RUPTURED WHILE IN THE PATIENT. THE WIRE AND BALLOON FELL APART. A SECOND CATHETER WAS INSERTED AND RUPTURED AS WELL. THERE WAS PATIENT INJURY, AS NOT ALL THE BROKEN PIECES COULD BE RETRIEVED. THE PATIENT WAS BROUGHT BACK TO THE OR FOR A FEMORAL-TIBIAL BYPASS THE NEXT DAY. THE PATIENT DEMOGRAPHICS WERE REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12652555 ↗