Safire™ 402808Recalls & reported problems
St. Jude Medical Cardiovascular Division · Bi-Directional Ablation Catheter · Class 3
- 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 05414734205993), received between Feb 11, 2020 and Feb 11, 2020 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (P960016); 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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Complete Heart Block1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE: 2184149-2020-00017. DURING A SLOW PATHWAY MODIFICATION FOR AN AV-NODAL REENTRANT TACHYCARDIA (AVNRT), HEART BLOCK OCCURRED. AFTER AN RF SESSION WAS BEING DELIVERED, IT WAS NOTICED THE CATHETER JUMPED OUT OF POSITION AND THE GENERATOR WAS REQUESTED TO BE CALLED OFF. THE RF WAS NOT CEASED UNTIL 4-5 SECONDS AFTER THE REQUEST. AV BLOCK OCCURRED DUE TO THE DELAYED RESPONSE IN TURNING OFF THE GENERATOR. THE PATIENT REQUIRED A PERMANENT PACEMAKER IMPLANT AND WAS IN A STABLE CONDITION.
Patient problems: Complete Heart Block
MAUDE report 9695981 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P960016. One submission often covers many models, so check the product and lot details in each record.
- Z-2313-2008 · Jun 5, 2008 · TerminatedThe St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm, Lot 2056960, Manufacturer St. Jude Medical 14901 DeVeau Place, M
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- THERMOCOOL SMARTTOUCH SF D134801Biosense Webster Inc · Cardiac ablation percutaneous catheter15 deaths608 reports
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- THERMOCOOL SMARTTOUCH SF D134702Biosense Webster Inc · Cardiac ablation percutaneous catheter19 deaths366 reports
- THERMOCOOL SMARTTOUCH SF D134701Biosense Webster Inc · Cardiac ablation percutaneous catheter11 deaths278 reports
- ThermoCool SmartTouch D133602Biosense Webster Inc · Cardiac ablation percutaneous catheter8 deaths225 reports
- SMARTABLATE SAT001Biosense Webster Inc · Cardiac ablation percutaneous catheter185 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.