Fogarty 120805FPRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00690103205220), received between Apr 21, 2022 and Jan 24, 2025 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (33 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K193379); 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.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE FOGARTY EMBOLECTOMY CATHETER "BALLOON WAS OPEN AND DEPLOYED" INSIDE THE PATIENT AND STARTED LEAKING. ONCE THE BALLOON WAS TESTED OUTSIDE OF THE PATIENT HOLES WERE VISIBLE ON THE BALLOON. THE CATHETER WAS NOT EXPIRED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229477 ↗
• MalfunctionJan 21, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE FOGARTY EMBOLECTOMY CATHETER "BALLOON WAS OPEN AND DEPLOYED" INSIDE THE PATIENT AND STARTED LEAKING. ONCE THE BALLOON WAS TESTED OUTSIDE OF THE PATIENT HOLES WERE VISIBLE ON THE BALLOON. THE CATHETER WAS NOT EXPIRED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21202297 ↗
• MalfunctionAug 22, 2024Material Rupture; Material Rupture

  AS REPORTED, DURING PROCEDURE WITH THIS FOGARTY EMBOLECTOMY CATHETER, THE BALLOON BURST. THERE IS NO ALLEGATION OF PATIENT INJURY. AS PER PRODUCT EVALUATION FINDINGS, THE BALLOON WAS FOUND TO BE RUPTURED AT CENTRAL AREA AND THE EDGES DID NOT APPEAR TO MATCH AT THE RUPTURED REGION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038430 ↗
• MalfunctionJun 21, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF A FOGARTY CATHETER WAS FOUND WITH PINHOLES. CATHETER WAS OPENED AND PREPPED IN THE STERILE FILED WHEN HOLES WERE NOTICED. THERE WAS NO PATIENT INVOLVEMENT. A PRODUCT EVALUATION WAS COMPLETED WITH THE RETURNED 120805F. THE REPORTED EVENT OF BALLOON ISSUE WAS CONFIRMED. BALLOON LATEX APPEARED DETERIORATED. MULTIPLE CRACKS AND TEARS WERE EVIDENT ON BALLOON LATEX. LEAKAGE WAS OBSERVED THROUGH THE TEARS ON THE BALLOON. BOTH BALLOON WINDINGS WERE INTACT. BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK BALLOON EDGES AT THE TEARS. THE EDGES DID NOT APPEAR TO MATCH AT THE TEARS. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM CATHETER BODY. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING OR DESIGN DEFECT. A CAPA WAS PREVIOUSLY INITIATED AND USED AS REFERENCE IN THE EVALUATION AS IT ADDRESSES THE "BALLOON - LATEX DETERIORATION" FAILURE FOR THE EMBOLECTOMY MODELS WITH A VASCUPOUCH PACKAGING. THE CAPA INVESTIGATION CONCLUDED THAT THE ROOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19585612 ↗
• MalfunctionJun 21, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF A FOGARTY CATHETER WAS FOUND WITH PINHOLES. CATHETER WAS OPENED AND PREPPED IN THE STERILE FILED WHEN HOLES WERE NOTICED. THERE WAS NO PATIENT INVOLVEMENT. A PRODUCT EVALUATION WAS COMPLETED WITH THE RETURNED 120805F. THE REPORTED EVENT OF BALLOON ISSUE WAS CONFIRMED. BALLOON LATEX APPEARED DETERIORATED. MULTIPLE CRACKS AND TEARS WERE EVIDENT ON BALLOON LATEX. LEAKAGE WAS OBSERVED THROUGH THE TEARS ON THE BALLOON. BOTH BALLOON WINDINGS WERE INTACT. BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK BALLOON EDGES AT THE TEARS. THE EDGES DID NOT APPEAR TO MATCH AT THE TEARS. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM CATHETER BODY. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING OR DESIGN DEFECT. A CAPA WAS PREVIOUSLY INITIATED AND USED AS REFERENCE IN THE EVALUATION AS IT ADDRESSES THE "BALLOON - LATEX DETERIORATION" FAILURE FOR THE EMBOLECTOMY MODELS WITH A VASCUPOUCH PACKAGING. THE CAPA INVESTIGATION CONCLUDED THAT THE ROOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19585029 ↗
• MalfunctionApr 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF AN EMBOLECTOMY CATHETER APPEARED TO BE DRY ROTTED. ISSUE WAS NOTICED DURING DEVICE PREP AND PRIOR TO SURGERY. STAFF COMMENTED THAT THE CATHETERS WERE PACKAGED IN THE NEW COVER AND NOT EXPIRED. THERE WERE NO PATIENT INJURIES REPORTED. THE DEVICE WAS RETURNED. PER PRODUCT EVALUATION, THE REPORTED EVENT OF BALLOON ISSUE WAS CONFIRMED. BALLOON LATEX APPEARED DETERIORATED. MULTIPLE CRACKS AND TEARS WERE EVIDENT ON BALLOON LATEX. LEAKAGE WAS OBSERVED THROUGH THE TEARS ON THE BALLOON. BOTH BALLOON WINDINGS WERE INTACT. BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK BALLOON EDGES AT THE TEARS. THE EDGES DID NOT APPEAR TO MATCH AT THE TEARS. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM CATHETER BODY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. 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 19188383 ↗
• MalfunctionApr 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF AN EMBOLECTOMY CATHETER APPEARED TO BE DRY ROTTED. ISSUE WAS NOTICED DURING DEVICE PREP AND PRIOR TO SURGERY. STAFF COMMENTED THAT THE CATHETERS WERE PACKAGED IN THE NEW COVER AND NOT EXPIRED. THERE WERE NO PATIENT INJURIES REPORTED. THE DEVICE WAS RETURNED. PER PRODUCT EVALUATION, THE REPORTED EVENT OF BALLOON ISSUE WAS CONFIRMED. BALLOON LATEX APPEARED DETERIORATED. MULTIPLE CRACKS AND TEARS WERE EVIDENT ON BALLOON LATEX. LEAKAGE WAS OBSERVED THROUGH THE TEARS ON THE BALLOON. BOTH BALLOON WINDINGS WERE INTACT. BALLOON LATEX WAS RELEASED FROM DISTAL WINDING TO CHECK BALLOON EDGES AT THE TEARS. THE EDGES DID NOT APPEAR TO MATCH AT THE TEARS. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM CATHETER BODY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. 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 19188326 ↗
• MalfunctionApr 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF AN EMBOLECTOMY CATHETER APPEARED TO BE DRY ROTTED. ISSUE WAS NOTICED DURING DEVICE PREP AND PRIOR TO SURGERY. STAFF COMMENTED THAT THE CATHETERS WERE PACKAGED IN THE NEW COVER AND NOT EXPIRED. THERE WERE NO PATIENT INJURIES REPORTED. THE DEVICE WAS RETURNED. PER PRODUCT EVALUATION, THE REPORTED EVENT OF BALLOON ISSUE WAS CONFIRMED. BALLOON LATEX APPEARED DETERIORATED. MULTIPLE CRACKS AND TEARS WERE EVIDENT ON BALLOON LATEX. LEAKAGE WAS OBSERVED THROUGH THE TEARS ON THE BALLOON. BOTH BALLOON WINDINGS WERE INTACT. BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK BALLOON EDGES AT THE TEARS. THE EDGES DID NOT APPEAR TO MATCH AT THE TEARS. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM CATHETER BODY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. 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 19188325 ↗
• MalfunctionJan 9, 2024Degraded; Material Fragmentation; Degraded; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER HAD AN INCIDENT ON NOVEMBER 1, 2023, WHERE AN EMBOLECTOMY CATHETER BALLOON FAILED DURING A PROCEDURE. THE 1.5 ML OF LIQUID WAS USED AS IFU REQUIRES AND THE BALLOON BURST UPON USE. FOGARTY ARTERIAL EMBOLECTOMY CATHETER, CATALOG # 120805FP, LOT # 64493859. CASE WAS COMPLETED USING ALTERNATIVE METHODS. THE CATHETER WAS NOT STORED IN A ROOM WHERE ULTRAVIOLET CLEANING UNITS ARE USED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480232 ↗
• MalfunctionJan 9, 2024Degraded; Material Fragmentation; Degraded; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER HAD AN INCIDENT ON (B)(6) 2023, WHERE AN EMBOLECTOMY CATHETER BALLOON FAILED DURING A PROCEDURE. THE 1.5 ML OF LIQUID WAS USED AS IFU REQUIRES AND THE BALLOON BURST UPON USE. FOGARTY ARTERIAL EMBOLECTOMY CATHETER, CATALOG # 120805FP, LOT # 64493859. CASE WAS COMPLETED USING ALTERNATIVE METHODS. THE CATHETER WAS NOT STORED IN A ROOM WHERE ULTRAVIOLET CLEANING UNITS ARE USED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480120 ↗
• MalfunctionDec 20, 2023Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT DURING DEVICE TESTING OF THIS FOGARTY CATHETER, THE BALLOON WAS FOUND TO HAVE A LEAK. THERE WERE PINHOLES IN THE BALLOON. THE ISSUE OCCURRED IN THE CARDIOVASCULAR OPERATING ROOM AT THE HOSPITAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370060 ↗
• MalfunctionJul 20, 2023Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture

  IT WAS REPORTED, THAT A 120804FP FOGARTY CATHETER HAD A BALLOON RUPTURE. DURING A RIGHT FEMORAL CUTDOWN THROMBOEMBOLECTOMY WITH ANGIO. THEY WERE USING DIFFERENT SIZES OF FOGARTY CATHETERS. EACH TIME THEY INJECTED THE APPROPRIATE AMOUNT OF FLUID, THE BALLOON WOULD BURST. THE STAFF DID GET A CATHETER TO WORK, AFTER GOING THROUGH SO MANY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17368030 ↗
• MalfunctionJul 20, 2023Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture

  IT WAS REPORTED, THAT A 120805F FOGARTY CATHETER HAD A BALLOON RUPTURE. DURING A RIGHT FEMORAL CUTDOWN THROMBOEMBOLECTOMY WITH ANGIO. THEY WERE USING DIFFERENT SIZES OF FOGARTY CATHETERS. EACH TIME THEY INJECTED THE APPROPRIATE AMOUNT OF FLUID, THE BALLOON WOULD BURST. THE STAFF DID GET A CATHETER TO WORK, AFTER GOING THROUGH SO MANY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17368027 ↗
• MalfunctionFeb 14, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON OF MULTIPLE FOGARTY CATHETERS FROM DIFFERENT LOT NUMBERS HAD HOLES IN THEM. THIS WAS DISCOVERED DURING USE OF THE DEVICE. THERE WAS NO ALLEGATION OF PATIENT INJURY. IT WAS REPORTED THAT THERE WERE ORIGINALLY SIX CATHETERS, BUT THE DECONTAMINATION LAB, AN EXTRA CATHETER WAS RETURNED. IT IS UNKNOWN WHAT THE ALLEGED FAILURE IS AND OR WHY THE CATHETER WAS RETURNED. THIS REPORT IS FOR A FOGARTY MODEL 120805FP, LOT 63677013, SAMPLE 7 OF 7 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372253 ↗
• MalfunctionFeb 8, 2023Material Fragmentation; Material Puncture/Hole; Material Fragmentation; Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON OF MULTIPLE FOGARTY CATHETERS FROM DIFFERENT LOT NUMBERS HAD HOLES IN THEM. THIS WAS DISCOVERED DURING USE OF THE DEVICE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THIS REPORT IS FOR A FOGARTY MODEL 120805FP, LOT 63677013, SAMPLE 6 OF 6 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329355 ↗
• MalfunctionFeb 7, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT 8 FOGARTY CATHETERS MODEL 120805FP FROM DIFFERENT LOT NUMBERS HAD MULTIPLE HOLES ON THEM. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THERE WAS NO ALLEGATION OF PATIENT HARM. THE CATHETERS ARE STORED ON A STERILE SHELF IN A TEMPERATURE-CONTROLLED ROOM IN THE OR. ONLY FOUR CATHETERS WERE AVAILABLE FOR RETURN. THIS REPORT IS FOR ONE OF THE CATHETERS FROM LOT 63735753.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315112 ↗
• MalfunctionFeb 7, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT 8 FOGARTY CATHETERS MODEL 120805FP FROM DIFFERENT LOT NUMBERS HAD MULTIPLE HOLES ON THEM. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THERE WAS NO ALLEGATION OF PATIENT HARM. THE CATHETERS ARE STORED ON A STERILE SHELF IN A TEMPERATURE-CONTROLLED ROOM IN THE OR. ONLY FOUR CATHETERS WERE AVAILABLE FOR RETURN. THIS REPORT IS FOR ONE OF THE CATHETERS FROM LOT 63735753.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16314937 ↗
• MalfunctionFeb 7, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT 8 FOGARTY CATHETERS MODEL 120805FP FROM DIFFERENT LOT NUMBERS HAD MULTIPLE HOLES ON THEM. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THERE WAS NO ALLEGATION OF PATIENT HARM. THE CATHETERS ARE STORED ON A STERILE SHELF IN A TEMPERATURE-CONTROLLED ROOM IN THE OR. ONLY FOUR CATHETERS WERE AVAILABLE FOR RETURN. THIS REPORT IS FOR ONE OF THE CATHETERS FROM LOT 63735753.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16314926 ↗
• MalfunctionJan 30, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOGARTY MODEL 120804F, LOT 64311189, BALLOON WOULD NOT EXPAND, PRIOR TO USE. THERE WAS NO PATIENT INJURY. THIS MDR IS FOR SAMPLE 1 OF 4 OF THE AFFECTED CATHETERS IN THIS INSTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264320 ↗
• MalfunctionJan 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHILE PREPPING A FOGARTY CATHETER, MODEL 120805FP, THE BALLOON POPPED OR HAD HOLES IN IT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16243719 ↗
• MalfunctionJan 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHILE PREPPING A FOGARTY CATHETER, MODEL 120805FP, THE BALLOON POPPED OR HAD HOLES IN IT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16243709 ↗
• MalfunctionJan 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHILE PREPPING A FOGARTY CATHETER, MODEL 120805FP, THE BALLOON POPPED OR HAD HOLES IN IT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241797 ↗
• MalfunctionJan 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHILE PREPPING A FOGARTY CATHETER, MODEL: 120805FP, THE BALLOON POPPED OR HAD HOLES IN IT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241784 ↗
• MalfunctionDec 5, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A FOGARTY CATHETER MODEL 120805FP, LOT 63776286, MALFUNCTIONED BEFORE INSERTION. THE BALLOON HAD INFLATION DIFFICULTIES. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15920934 ↗
• MalfunctionDec 5, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A FOGARTY CATHETER MODEL 120805FP, LOT 63724804, MALFUNCTIONED BEFORE INSERTION. THE BALLOON HAD INFLATION DIFFICULTIES. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15920310 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193379. One submission often covers many models, so check the product and lot details in each record.

• Z-0147-2023 · Oct 6, 2022 · Open, Classified
  Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP