Home › IRVINE BIOMEDICAL, INC. › Therapy™
Therapy™
IRVINE BIOMEDICAL, INC. · Model IBI-84308 · UDI-DI 05414734308564
OAD
Prescription
0
510(k) clearances
5,946
Adverse events (218 deaths)
22
Recalls
52
Facilities
Description
Ablation Catheter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-11 | Medtronic, Inc. | Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillat |
| 2022-09-07 | Johnson & Johnson Surgical Vision, Inc. | Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing in |
| 2018-11-28 | Boston Scientific Corporation | Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not refle |
| 2018-11-28 | Boston Scientific Corporation | Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not refle |
| 2018-11-28 | Boston Scientific Corporation | Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not refle |
| 2018-06-20 | Boston Scientific Corporation | Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released. |
| 2015-11-20 | Boston Scientific Corp | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSCs product risk docu |
| 2015-11-20 | Boston Scientific Corp | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSC's product risk doc |
| 2015-11-20 | Boston Scientific Corp | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSCs product risk docu |
| 2015-11-20 | Boston Scientific Corp | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSC's product risk doc |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.