SJM™ IBI-85641Recalls & reported problems
Irvine Biomedical, Inc. · Electrophysiology Cable · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734308755), received between Oct 18, 2021 and Oct 18, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “High impedance” (1 report).
3 other recalls cover devices cleared under the same FDA submission (P040014); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- High impedance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2021High impedance; High impedance
DURING A WOLFF-PARKINSON-WHITE SYNDROME ABLATION PROCEDURE, A PROLONGED PROCEDURE OCCURRED DUE TO A HIGH IMPEDANCE AND THE TROUBLESHOOTING INVOLVED IN ORDER TO RESOLVE THE ISSUE. FOLLOWING MAPPING OF THE ACCESSORY PATHWAY, THE 1641 CABLE CONNECTOR WAS INSERTED INTO THE CATHETER AND A HIGH IMPEDANCE MESSAGE WAS OBSERVED. MULTIPLE TROUBLESHOOTING STEPS WERE CONDUCTED, BUT THE ISSUE REMAINED. THE 1641 CABLE WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12647982 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P040014. One submission often covers many models, so check the product and lot details in each record.
- Z-3257-2011 · Feb 10, 2011 · Terminated7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83726, Description: 1304-7-25-XL-TH. St Jude Medical Company A sterile, single use catheter with one 4mm a
- Z-3256-2011 · Feb 10, 2011 · Terminated7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83725, Description: 1304-7-25-L-TH. St Jude Medical Company A sterile, single use catheter with one 4mm ab
- Z-3255-2011 · Feb 10, 2011 · Terminated7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83724, Description: 1304-7-25-M-TH. St Jude Medical Company A sterile, single use catheter with one 4mm a
Other Cardiac ablation percutaneous catheter devices
- THERMOCOOL SMARTTOUCH SF D134805Biosense Webster Inc · Cardiac ablation percutaneous catheter1 recall176 deaths4,106 reports
- THERMOCOOL SMARTTOUCH SF D134804Biosense Webster Inc · Cardiac ablation percutaneous catheter44 deaths784 reports
- THERMOCOOL SMARTTOUCH SF D134801Biosense Webster Inc · Cardiac ablation percutaneous catheter15 deaths608 reports
- ThermoCool SmartTouch D132705Biosense Webster Inc · Cardiac ablation percutaneous catheter25 deaths574 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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