Recall Z-3012-2020— Irvine Biomedical Inc, a St. Jude Medical Co.

Name: FDA recall Z-3012-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-24

Class II · Terminated

Class II FDA medical device recall by Irvine Biomedical Inc, a St. Jude Medical Co., initiated 2020-08-24, terminated 2023-07-31. It names one FDA 510(k) clearance: K961924. Product: 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.. Reason: 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.

Recalling firm: Irvine Biomedical Inc, a St. Jude Medical Co.
Classification: Class II
Status: Terminated
Initiated: 2020-08-24
Terminated: 2023-07-31
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K961924 — IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEMIrvine Biomedical, Inc.·cleared 1997-04-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.