Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - 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 steerable diagnostic catheters due to a packaging mix-up affecting 40 units. Packages labeled Model IBI-81104, batch 7397352 contained Model IBI-87002, batch 7397307, while packages labeled Model IBI-87002, batch 7397307 contained Model IBI-81104, batch 7397352. The affected catheters were distributed worldwide, including locations in Missouri, Indiana, Wisconsin, Texas, Arizona, Michigan, Virginia, Kentucky, and Japan.
If physicians do not notice the catheter difference during use, the intracardiac electrograms may not provide the intended signals, potentially delaying the procedure. The product recall record does not specify a remedy or action that affected consumers should take.
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: 40 units Lot/code info: GTIN: 05414734309936, Lot: 7397307
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.