Therapy™ IBI-83365Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734306928), received between Dec 16, 2020 and Dec 16, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2020Material Frayed; Difficult to Remove; Activation, Positioning or Separation Problem; Material Frayed; Difficult to Remove; Activation, Positioning or Separation Problem

  DURING THE PROCEDURE, THE CATHETER WAS INSERTED IN THE USUAL FASHION VIA ARTERIAL SHEATH. UPON ADVANCEMENT TO AND FROM THE HEART, THE CATHETER LOOPED AROUND ITSELF. THE CATHETER WAS STRAIGHTENED OUT SUCCESSFULLY AND PULLED OUT OF THE SHEATH. IT WAS NOTED THAT THE COATING ON THE SHAFT HAD BEEN DAMAGED, WHICH BOTH PREVENTED THE DEFLECTION MECHANISM FROM FUNCTIONING PROPERLY AND EXPOSED INTERNAL CATHETER COMPONENTS. THE ABLATION CATHETER WAS REPLACED WITH A FLEXIBILITY ABLATION CATHETER TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11018973 ↗

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-3255-2011 · Feb 10, 2011 · Terminated
  7 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
• Z-3256-2011 · Feb 10, 2011 · Terminated
  7 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-3257-2011 · Feb 10, 2011 · Terminated
  7 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