Irvine Biomedical Inc, a St. Jude Medical Co.: Medical Device Recall in 2020 - (Recall #: Z-3012-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 the high right atrium, right ventricular apex, and HIS bundle.

Product Classification:

Class II

Date Initiated: August 24, 2020

Date Posted: September 30, 2020

Recall Number: Z-3012-2020

Event ID: 86328

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

Status: Terminated

Product Quantity: 40 units

Code Information:

GTIN: 05414734309936, Lot: 7397307

Distribution Pattern:

Worldwide distribution - U.S. Nationwide distribution including the states of MO, IN, WI, TX, AZ, MI, VA, KY and the country of Japan.

Voluntary or Mandated:

Voluntary: Firm initiated