Fogarty 120804FPRecalls & reported problems

Summary

The FDA's MAUDE database contains 200 adverse event reports that list this exact device (DI 00690103205213), received between Jul 14, 2021 and Nov 19, 2024 — classified as 1 death, 1 injury, 198 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (154 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 200 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2024Degraded; Degraded

  IT WAS REPORTED THAT A BALLOON WAS OPENED AND DEPLOYED INSIDE PATIENT AND THE BALLOON WAS LEAKING. ONCE TESTED OUTSIDE PATIENT, HOLES WERE VISIBLE ON THE BALLOONS. THEY WERE NOT EXPIRED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20719077 ↗
• MalfunctionNov 18, 2024Degraded; Degraded

  IT WAS REPORTED THAT A BALLOON WAS OPENED AND DEPLOYED INSIDE PATIENT AND THE BALLOON WAS LEAKING. ONCE TESTED OUTSIDE PATIENT, HOLES WERE VISIBLE ON THE BALLOONS. THEY WERE NOT EXPIRED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20716053 ↗
• MalfunctionNov 18, 2024Degraded; Degraded

  IT WAS REPORTED THAT A BALLOON WAS OPENED AND DEPLOYED INSIDE PATIENT AND THE BALLOON WAS LEAKING. ONCE TESTED OUTSIDE PATIENT, HOLES WERE VISIBLE ON THE BALLOONS. THEY WERE NOT EXPIRED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20715912 ↗
• MalfunctionNov 18, 2024Degraded; Degraded

  IT WAS REPORTED THAT A BALLOON WAS OPENED AND DEPLOYED INSIDE PATIENT AND THE BALLOON WAS LEAKING. ONCE TESTED OUTSIDE PATIENT, HOLES WERE VISIBLE ON THE BALLOONS. THEY WERE NOT EXPIRED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20715423 ↗
• MalfunctionNov 18, 2024Degraded; Degraded

  IT WAS REPORTED THAT A BALLOON WAS OPENED AND DEPLOYED INSIDE PATIENT AND THE BALLOON WAS LEAKING. ONCE TESTED OUTSIDE PATIENT, HOLES WERE VISIBLE ON THE BALLOONS. THEY WERE NOT EXPIRED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20714582 ↗
• MalfunctionSep 4, 2024Degraded; Degraded

  AS REPORTED, WHEN OPENING THE PACKAGE OF THIS FOGARTY EMBOLECTOMY CATHETER, THE BALLOON WAS FOUND PUNCTURED. FINALLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A MINOR SIZE DEVICE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE CATHETER WAS RECEIVED FOR EVALUATION, AND THE BALLOON LATEX APPEARED DETERIORATED AND TORN IN THE DISTAL AREA AND TIP. MULTIPLE CRACKS AND TEARS WERE EVIDENT ON THE BALLOON LATEX. BALLOON LATEX TIP WAS MISSING AND NOT RETURNED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20133410 ↗
• MalfunctionSep 4, 2024Degraded; Degraded

  AS REPORTED, WHEN OPENING THE PACKAGE OF THIS FOGARTY EMBOLECTOMY CATHETER, THE BALLOON WAS FOUND PUNCTURED. FINALLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A MINOR SIZE DEVICE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE CATHETER WAS RECEIVED FOR EVALUATION, AND THE BALLOON LATEX APPEARED DETERIORATED AND TORN IN THE DISTAL AREA AND TIP. MULTIPLE CRACKS AND TEARS WERE EVIDENT ON THE BALLOON LATEX. BALLOON LATEX TIP WAS MISSING AND NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20133409 ↗
• MalfunctionMay 23, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED VIA MEDWATCH (B)(4) THE TIP OF A FOGARTY CATHETER LOOKED CHIPPED AND SLIGHTLY FRAYED. THE BALLOON WOULD NOT INFLATE AND SALINE LEAKED FROM MULTIPLE HOLES ON ALL CATHETERS. PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. THERE WERE NO PATIENT HARM. A PRODUCT EVALUATION OF THE RETURNED 120804F WAS RETURNED. THE REPORTED EVENT OF BALLOON ISSUE WAS CONFIRMED. BALLOON LATEX APPEARED DETERIORATED. MULTIPLE CRACKS AND A TEAR WERE EVIDENT ON BALLOON LATEX. LEAKAGE WAS OBSERVED THROUGH THE TEAR ON THE BALLOON. BOTH BALLOON WINDINGS WERE INTACT. BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK BALLOON EDGES AT THE TEAR. THE EDGES DID NOT APPEAR TO MATCH AT THE TEAR. 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. 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 19389076 ↗
• MalfunctionMay 23, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED VIA MEDWATCH (B)(4) THE TIP OF A FOGARTY CATHETER LOOKED CHIPPED AND SLIGHTLY FRAYED. THE BALLOON WOULD NOT INFLATE AND SALINE LEAKED FROM MULTIPLE HOLES ON ALL CATHETERS. PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. THERE WERE NO PATIENT HARM. A PRODUCT EVALUATION OF THE RETURNED 120804F WAS RETURNED. 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 A TEAR ON THE BALLOON. BOTH BALLOON WINDINGS WERE INTACT. BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK BALLOON EDGES AT THE TEAR. THE EDGES DID NOT APPEAR TO MATCH AT THE TEAR. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM CATHETER BODY. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. 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 19388811 ↗
• 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 A TEAR WERE EVIDENT ON BALLOON LATEX. LEAKAGE WAS OBSERVED THROUGH THE TEAR ON THE BALLOON. BOTH BALLOON WINDINGS WERE INTACT. BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK BALLOON EDGES AT THE TEAR. THE EDGES DID NOT APPEAR TO MATCH AT THE TEAR. 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 19188324 ↗
• 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 19188307 ↗
• MalfunctionApr 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN OPENED THIS 120804FP FOGARTY CATHETER WAS FOUND TO HAVE THE BALLOON POPPED. THERE WAS NO PATIENT INJURY. OUR PRODUCT LAB RECEIVED ONE 120804F CATHETER. THE REPORTED ISSUE OF THE BALLOON POPPED WAS CONFIRMED. THE BALLOON LATEX APPEARED DETERIORATED. THE BALLOON WAS COMPLETELY TORN AROUND THE DISTAL WINDINGS. MULTIPLE CRACKS WERE EVIDENT ON THE BALLOON LATEX. BOTH BALLOON WINDINGS WERE INTACT. THE BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK THE BALLOON EDGES AT THE TEAR. THE EDGES DID NOT APPEAR TO MATCH AT THE TEAR. LATEX DETERIORATION IS A CONDITION USUALLY CAUSED BY AGE, EXCESSIVE EXPOSURE TO LIGHT, ATMOSPHERE, OR OZONE. APPEARS ON THE BALLOON SURFACE AS A MAZE OF FINE CRACKS OR CRAZING. THE CONDITION MAY OCCUR IN A SMALL AREA OR COVER THE ENTIRE BALLOON. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM THE CATHETER BODY.AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE STORAGE CONDITIONS FOR THESE CATHETERS ARE SPECIFIED IN THE IFU. A PRODUCT RISK ASSESSMENT ADDRESSES BALLOONS WITH FRAGMENTATIONS FOR EMBOLECTOMY CATHETERS, AND A CORRECTIVE AND PREVENTIVE ACTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076499 ↗
• MalfunctionApr 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN OPENED THIS 120804FP FOGARTY CATHETER WAS FOUND TO HAVE THE BALLOON POPPED. THERE WAS NO PATIENT INJURY. OUR PRODUCT LAB RECEIVED ONE 120804F CATHETER. THE REPORTED ISSUE OF THE BALLOON POPPED WAS CONFIRMED. THE BALLOON LATEX APPEARED DETERIORATED. THE BALLOON WAS COMPLETELY TORN AROUND THE DISTAL WINDINGS. MULTIPLE CRACKS WERE EVIDENT ON THE BALLOON LATEX. BOTH BALLOON WINDINGS WERE INTACT. THE BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK THE BALLOON EDGES AT THE TEAR. THE EDGES DID NOT APPEAR TO MATCH AT THE TEAR. LATEX DETERIORATION IS A CONDITION USUALLY CAUSED BY AGE, EXCESSIVE EXPOSURE TO LIGHT, ATMOSPHERE, OR OZONE. APPEARS ON THE BALLOON SURFACE AS A MAZE OF FINE CRACKS OR CRAZING. THE CONDITION MAY OCCUR IN A SMALL AREA OR COVER THE ENTIRE BALLOON. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM THE CATHETER BODY. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE STORAGE CONDITIONS FOR THESE CATHETERS ARE SPECIFIED IN THE IFU. A PRODUCT RISK ASSESSMENT ADDRESSES BALLOONS WITH FRAGMENTATIONS FOR EMBOLECTOMY CATHETERS, AND A CORRECTIVE AND PREVENTIVE ACTIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076494 ↗
• MalfunctionApr 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN OPENED THIS 120804FP FOGARTY CATHETER WAS FOUND TO HAVE THE BALLOON POPPED. THERE WAS NO PATIENT INJURY. OUR PRODUCT LAB RECEIVED ONE 120804F CATHETER. THE REPORTED ISSUE OF THE BALLOON POPPED WAS CONFIRMED. THE BALLOON LATEX APPEARED DETERIORATED. THERE WERE MULTIPLE CRACKS AND TEARS EVIDENT ON THE BALLOON LATEX. LEAKAGE WAS OBSERVED THROUGH THE TEARS ON THE BALLOON. BOTH BALLOON WINDINGS WERE INTACT. THE BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK THE BALLOON EDGES AT THE TEARS. THE EDGES DID NOT APPEAR TO MATCH AT THE TEARS. LATEX DETERIORATION IS A CONDITION USUALLY CAUSED BY AGE, EXCESSIVE EXPOSURE TO LIGHT, ATMOSPHERE, OR OZONE. APPEARS ON THE BALLOON SURFACE AS A MAZE OF FINE CRACKS OR CRAZING. THE CONDITION MAY OCCUR IN A SMALL AREA OR COVER THE ENTIRE BALLOON. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM THE CATHETER BODY. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE STORAGE CONDITIONS FOR THESE CATHETERS ARE SPECIFIED IN THE IFU. A PRODUCT RISK ASSESSMENT ADDRESSES BALLOONS WITH FRAGMENTATIONS FOR EMBOLECTOMY CATHETERS, AND A CORRECTIVE AND PRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076492 ↗
• MalfunctionApr 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN OPENED THIS 120804FP FOGARTY CATHETER WAS FOUND TO HAVE THE BALLOON POPPED. THERE WAS NO PATIENT INJURY. OUR PRODUCT LAB RECEIVED ONE 120804F CATHETER. THE REPORTED ISSUE OF THE BALLOON POPPED WAS CONFIRMED. THE BALLOON LATEX APPEARED DETERIORATED. THERE WERE MULTIPLE CRACKS AND TEARS EVIDENT ON THE BALLOON LATEX. LEAKAGE WAS OBSERVED THROUGH THE TEARS ON THE BALLOON. BOTH BALLOON WINDINGS WERE INTACT. THE BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK THE BALLOON EDGES AT THE TEARS. THE EDGES DID NOT APPEAR TO MATCH AT THE TEARS. LATEX DETERIORATION IS A CONDITION USUALLY CAUSED BY AGE, EXCESSIVE EXPOSURE TO LIGHT, ATMOSPHERE, OR OZONE. APPEARS ON THE BALLOON SURFACE AS A MAZE OF FINE CRACKS OR CRAZING. THE CONDITION MAY OCCUR IN A SMALL AREA OR COVER THE ENTIRE BALLOON. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM THE CATHETER BODY. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE STORAGE CONDITIONS FOR THESE CATHETERS ARE SPECIFIED IN THE IFU. A PRODUCT RISK ASSESSMENT ADDRESSES BALLOONS WITH FRAGMENTATIONS FOR EMBOLECTOMY CATHETERS, AND A CORRECTIVE AND PRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076470 ↗
• MalfunctionApr 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN OPENED THIS 120804FP FOGARTY CATHETER WAS FOUND TO HAVE THE BALLOON POPPED. THERE WAS NO PATIENT INJURY. OUR PRODUCT LAB RECEIVED ONE 120804F CATHETER. THE REPORTED ISSUE OF THE BALLOON POPPED WAS CONFIRMED. THE BALLOON LATEX APPEARED DETERIORATED. THERE WERE MULTIPLE CRACKS AND TEARS EVIDENT ON THE BALLOON LATEX. LEAKAGE WAS OBSERVED THROUGH THE TEARS ON THE BALLOON. BOTH BALLOON WINDINGS WERE INTACT. THE BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK THE BALLOON EDGES AT THE TEARS. THE EDGES DID NOT APPEAR TO MATCH AT THE TEARS. LATEX DETERIORATION IS A CONDITION USUALLY CAUSED BY AGE, EXCESSIVE EXPOSURE TO LIGHT, ATMOSPHERE, OR OZONE. APPEARS ON THE BALLOON SURFACE AS A MAZE OF FINE CRACKS OR CRAZING. THE CONDITION MAY OCCUR IN A SMALL AREA OR COVER THE ENTIRE BALLOON. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM THE CATHETER BODY. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE STORAGE CONDITIONS FOR THESE CATHETERS ARE SPECIFIED IN THE IFU. A PRODUCT RISK ASSESSMENT ADDRESSES BALLOONS WITH FRAGMENTATIONS FOR EMBOLECTOMY CATHETERS, AND A CORRECTIVE AND PRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075659 ↗
• MalfunctionApr 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER HAD A FR CATHETER THAT HAD FAULTY BALLOONS. PER THE CUSTOMER, THE BALLOON LOOKED DAMAGED/NOT INTACT BEFORE IT WAS USED IN THE PATIENT. THERE WAS NOT ANY TROUBLESHOOTING. THERE WAS NO PATIENT INJURY. DEVICE IS AVAILABLE FOR RETURN. OUR PRODUCT EVALUATION LAB RECEIVED ONE MODEL 120804F FOGARTY CATHETER. THE CUSTOMER REPORT OF FAULTY BALLOONS 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 TEAR. THE EDGES DID NOT APPEAR TO MATCH AT THE TEARS. LATEX DETERIORATION IS A CONDITION USUALLY CAUSED BY AGE, EXCESSIVE EXPOSURE TO LIGHT, ATMOSPHERE, OR OZONE. APPEARS ON THE BALLOON SURFACE AS A MAZE OF FINE CRACKS OR CRAZING. THE CONDITION MAY OCCUR IN A SMALL AREA OR COVER THE ENTIRE BALLOON. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM CATHETER BODY. AN ENGINEERING EVALUATION WAS PERFORMED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068314 ↗
• MalfunctionApr 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER HAD A FR CATHETER THAT HAD FAULTY BALLOONS. PER THE CUSTOMER, THE BALLOON LOOKED DAMAGED/NOT INTACT BEFORE IT WAS USED IN THE PATIENT. THERE WAS NOT ANY TROUBLESHOOTING. THERE WAS NO PATIENT INJURY. DEVICE IS AVAILABLE FOR RETURN. OUR PRODUCT EVALUATION LAB RECEIVED ONE MODEL 120804F FOGARTY CATHETER. THE CUSTOMER REPORT OF FAULTY BALLOONS 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 TEAR. THE EDGES DID NOT APPEAR TO MATCH AT THE TEARS. LATEX DETERIORATION IS A CONDITION USUALLY CAUSED BY AGE, EXCESSIVE EXPOSURE TO LIGHT, ATMOSPHERE, OR OZONE. APPEARS ON THE BALLOON SURFACE AS A MAZE OF FINE CRACKS OR CRAZING. THE CONDITION MAY OCCUR IN A SMALL AREA OR COVER THE ENTIRE BALLOON. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM CATHETER BODY. AN ENGINEERING EVALUATION WAS PERFORMED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067618 ↗
• MalfunctionApr 5, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A CASE THE BALLOON BROKE DURING INFLATION ON THIS FOGARTY CATHETER. THERE WAS NO PATIENT INJURY. OUR PRODUCT EVALUATION LAB RECEIVED ONE MODEL 120804F CATHETER. THE REPORTED ISSUE THAT THE BALLOON BROKE WAS CONFIRMED. THE BALLOON LATEX APPEARED DETERIORATED. MULTIPLE CRACKS AND TEARS WERE EVIDENT ON THE BALLOON LATEX. LEAKAGE WAS OBSERVED THROUGH THE TEARS ON THE BALLOON. BOTH BALLOON WINDINGS WERE INTACT. THE BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK THE BALLOON EDGES AT THE TEARS. THE EDGES DID NOT APPEAR TO MATCH AT THE RUPTURE. LATEX DETERIORATION IS A CONDITION USUALLY CAUSED BY AGE, EXCESSIVE EXPOSURE TO LIGHT, ATMOSPHERE, OR OZONE. APPEARS ON THE BALLOON SURFACE AS A MAZE OF FINE CRACKS OR CRAZING. THE CONDITION MAY OCCUR IN A SMALL AREA OR COVER THE ENTIRE BALLOON. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM THE CATHETER BODY.AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE STORAGE CONDITIONS FOR THESE CATHETERS ARE SPECIFIED IN THE IFU. A PRODUCT RISK ASSESSMENT ADDRESSES BALLOONS WITH FRAGMENTATIONS FOR EMBOLECTOMY CATHETERS, AND A CORRECTIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055721 ↗
• MalfunctionApr 5, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A CASE THE BALLOON BROKE DURING INFLATION ON THIS FOGARTY CATHETER. THERE WAS NO PATIENT INJURY. OUR PRODUCT EVALUATION LAB RECEIVED ONE MODEL 120804F CATHETER. THE REPORTED ISSUE THAT THE BALLOON BROKE WAS CONFIRMED. THE BALLOON LATEX APPEARED DETERIORATED AND WAS RUPTURED. MULTIPLE CRACKS WERE EVIDENT ON THE BALLOON LATEX. BOTH BALLOON WINDINGS WERE INTACT. THE BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK THE BALLOON EDGES AT THE RUPTURE. THE EDGES DID NOT APPEAR TO MATCH AT THE RUPTURE. LATEX DETERIORATION IS A CONDITION USUALLY CAUSED BY AGE, EXCESSIVE EXPOSURE TO LIGHT, ATMOSPHERE, OR OZONE. APPEARS ON THE BALLOON SURFACE AS A MAZE OF FINE CRACKS OR CRAZING. THE CONDITION MAY OCCUR IN A SMALL AREA OR COVER THE ENTIRE BALLOON. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM THE CATHETER BODY. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE STORAGE CONDITIONS FOR THESE CATHETERS ARE SPECIFIED IN THE IFU. A PRODUCT RISK ASSESSMENT ADDRESSES BALLOONS WITH FRAGMENTATIONS FOR EMBOLECTOMY CATHETERS, AND A CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) WAS CREATED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055705 ↗
• MalfunctionApr 5, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A CASE THE BALLOON BROKE DURING INFLATION ON THIS FOGARTY CATHETER. THERE IS WAS NO PATIENT INJURY. OUR PRODUCT EVALUATION LAB RECEIVED ONE MODEL 120804F CATHETER. THE REPORTED ISSUE THAT THE BALLOON BROKE WAS CONFIRMED. THE BALLOON LATEX APPEARED DETERIORATED. CRACKS AND A TEAR WERE EVIDENT ON THE BALLOON LATEX. LEAKAGE WAS OBSERVED THROUGH THE TEAR ON THE BALLOON. BOTH BALLOON WINDINGS WERE INTACT. THE BALLOON LATEX WAS RELEASED FROM THE BALLOON WINDINGS TO CHECK BALLOON EDGES AT THE TEARS. THE EDGES DID NOT APPEAR TO MATCH AT ONE OF THE TEARS. LATEX DETERIORATION IS A CONDITION USUALLY CAUSED BY AGE, EXCESSIVE EXPOSURE TO LIGHT, ATMOSPHERE, OR OZONE. APPEARS ON THE BALLOON SURFACE AS A MAZE OF FINE CRACKS OR CRAZING. THE CONDITION MAY OCCUR IN A SMALL AREA OR COVER THE ENTIRE BALLOON. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM THE CATHETER BODY. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE STORAGE CONDITIONS FOR THESE CATHETERS ARE SPECIFIED IN THE IFU. A PRODUCT RISK ASSESSMENT ADDRESSES BALLOONS WITH FRAGMENTATIONS FOR EMBOLECTOMY CATHETERS, AND A CORRECTIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055700 ↗
• MalfunctionMar 28, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF THIS FOGARTY ARTERIAL EMBOLECTOMY CATHETER APPEARED TO BE DRY ROTTED. THERE WAS NO ALLEGATION OF PATIENT INJURY. OUR PRODUCT EVALUATION LAB RECEIVED ONE MODEL: 120804FP EMBOLECTOMY CATHETER. THE CUSTOMER REPORT OF BALLOON ISSUE WAS CONFIRMED. BALLOON LATEX APPEARED DETERIORATED. THE BALLOON RUPTURED DURING INFLATION TEST. BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK BALLOON EDGES AT THE RUPTURE. THE EDGES DID NOT APPEAR TO MATCH AT THE RUPTURE. LATEX DETERIORATION IS A CONDITION USUALLY CAUSED BY AGE, EXCESSIVE EXPOSURE TO LIGHT, ATMOSPHERE, OR OZONE. APPEARS ON THE BALLOON SURFACE AS A MAZE OF FINE CRACKS OR CRAZING. THE CONDITION MAY OCCUR IN A SMALL AREA OR COVER THE ENTIRE BALLOON. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM CATHETER BODY. AN ENGINEERING EVALUATION WAS PERFORMED 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/DESIGN DEFECT. A CAPA WAS INITIATED TO ADDRESS THE BALLOON - LATEX DETERIORATION FAILURE FOR THE EMBOLECTOMY MODELS WITH A VASCUPOUCH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18998569 ↗
• MalfunctionMar 21, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A FOGARTY BALLOON APPEARED TO BE DRY ROTTED. THIS WAS FOUND DURING DEVICE PREP, THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956133 ↗
• DeathMar 20, 2024Break; Break

  IT WAS REPORTED IN MEDWATCH (B)(4).THAT THERE WAS A FAILURE WITH THE FOGARTY EMBOLECTOMY CATHETER. A 3 FRENCH FOGARTY CATHETER WAS PLACED RETROGRADE IN THE SUPERFICIAL FEMORAL ARTERY SFA. FRESH THROMBUS WAS REMOVED. THEN A 4 FRENCH FOGARTY CATHETER WAS PLACED AND A SECOND PASS WAS PERFORMED BUT IT BECAME LODGED AS IT WAS BEING PULLED BACK. THERE WERE MANY MANIPULATIONS ATTEMPTED, BUT THEY WERE UNABLE TO DISLODGE IT. NEGATIVE PRESSURE WAS PLACED ON THE CATHETER AND THEN TRACTION PLACED. THE BALLOON RUPTURED AND THEN THE CATHETER CAME OUT. IT APPEARED THAT SOME OF THE BALLOON REMAINED IN THE PATIENT. AN ANGIOGRAM WAS PERFORMED DOWN THE LEG. THERE APPEARED TO BE A SEVERE STENOSIS IN THE PROXIMAL THIRD OF THE SFA 80 PERCENT. IT LOOKED AS THOUGH THE BALLOON HAD BECOME STUCK AT THE LOCATION OF THE SEVERE STENOSIS. THE BALLOON WAS SUCCESSFULLY RETRIEVED THROUGH A FASCIOTOMY. THROUGH FOLLOW UP WITH THE FACILITY IT WAS DETERMINED THAT THE PATIENT STATUS IS DECEASED. DATE OF DEATH AND CAUSE HAVE BEEN REQUESTED FROM THE FACILITY WITH NO RESPONSE. FOLLOW UP FOR MORE INFORMATION IS STILL ONGOING. THE 4 FRENCH FOGARTY CATHETER WAS DISCARDED AND NOT AVAILABLE FOR EVALUATION.

  Patient problems: Foreign Body Embolism

  MAUDE report 18946501 ↗
• MalfunctionMar 6, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A CASE THE BALLOON BROKE DURING INFLATION ON THIS FOGARTY CATHETER. THERE IS WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852296 ↗

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