FOGARTY 410236FPRecalls & reported problems
Edwards Lifesciences LLC · FOGARTY BILIARY BALLOON PROBE 6F 23CM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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
- Oct 6, 2022Open, Classified
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
Z-0147-2023 · Root cause: Packaging · FDA record ↗
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-0146-2023 · Oct 6, 2022 · Open, ClassifiedFogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Mod
Other Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection devices
- FOGARTY 410405FPEdwards Lifesciences LLC · Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection1 recall0 reports
- FOGARTY 410235FPEdwards Lifesciences LLC · Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection1 recall0 reports
- Fusion Quattro G48225Cook Incorporated · CATHETER, BILIARY, SURGICAL22 reports
- Fusion G31537Cook Incorporated · CATHETER, BILIARY, SURGICAL15 reports
- Fusion Quattro G31922Cook Incorporated · CATHETER, BILIARY, SURGICAL5 reports
- Tri-Ex G26856Cook Incorporated · CATHETER, BILIARY, SURGICAL4 reports
- Fusion Quattro G31921Cook Incorporated · CATHETER, BILIARY, SURGICAL4 reports
- Fusion Quattro G48226Cook Incorporated · CATHETER, BILIARY, SURGICAL3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page