Therapy™ IBI-83371Recalls & reported problems
Irvine Biomedical, Inc. · Ablation Catheter · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734306980), received between Mar 2, 2022 and Mar 2, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
4 other recalls cover devices cleared under the same FDA submission (P040042); 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
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
RELATED MANUFACTURER REPORT NUMBER 1627487-2022-01156; RELATED MANUFACTURER REPORT NUMBER 1627487-2022-01160. IT WAS REPORTED THAT PATIENT HAD NOT USED OR CHARGED THEIR DEVICE IN 5 TO 6 YEARS AND HAD ADDED TO THEIR PAIN. PATIENT DID NOT HAVE EFFECTIVE THERAPY. THE IPG WAS EXPLANTED. THE LEADS WERE ATTEMPTED TO BE EXPLANTED HOWEVER THE PHYSICIAN WAS UNABLE TO DUE TO DIFFICULTY IN REMOVING. PHYSICIAN RECOMMENDED PATIENT TO ANOTHER FACILITY FOR LEAD EXPLANT. LEADS REMAIN FULLY INTACT AND IMPLANTED. NO SURGERY DATE IS SET FOR LEAD EXPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Implant Pain
MAUDE report 13653238 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P040042. One submission often covers many models, so check the product and lot details in each record.
- Z-0594-2010 · Nov 25, 2009 · TerminatedPowerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000.
- Z-0593-2010 · Nov 25, 2009 · TerminatedPowerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80L, LOTS W09-2966 AND W09-2998.
- Z-0309-2007 · Nov 8, 2006 · TerminatedEndologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model Number 25-16-155BL
- Z-0310-2007 · Nov 8, 2006 · TerminatedEndologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL
Other catheter, percutaneous, cardiac ablation, for treatment of atrial flutter devices
- QDOT MICRO D139505Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter27 deaths915 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR96200Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter4 deaths269 reports
- QDOT MICRO D139504Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter7 deaths138 reports
- Sphere-9™ Catheter AFR-00001Medtronic, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 recall5 deaths77 reports
- QDOT MICRO D139401Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 deaths114 reports
- NaviStar ThermoCool NI75TCDHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter111 reports
- NaviStar RMT ThermoCool NR7TCSIYBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter9 deaths103 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR9620K20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter78 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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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