Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at th
Check against the official notice below — it lists the full affected range.
Irvine Biomedical Inc., a St. Jude Medical company, recalled Inquiry steerable diagnostic catheters due to a labeling mix-up affecting 15 units worldwide. Packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307, while packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352. The affected catheters were distributed across multiple U.S. states (Missouri, Indiana, Wisconsin, Texas, Arizona, Michigan, Virginia, Kentucky) and Japan.
If physicians do not notice the catheter difference during use, the intracardiac electrograms will not represent the desired signals and could result in procedure delays. The source document does not specify what action affected consumers or healthcare providers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352.If physicians fail to observe the catheter difference, the intracardiac electrograms will not be representative of the desired signals, could result in procedure delay
Reason for recall: Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352.If physicians fail to observe the catheter difference, the intracardiac electrograms will not be representative of the desired signals, could result in procedure delay Distribution: Worldwide distribution - U.S. Nationwide distribution including the states of MO, IN, WI, TX, AZ, MI, VA, KY and the country of Japan. Quantity: 15 units Lot/code info: GTIN: 05414734302975, Lot: 7397352
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.