Z-3012-2020Class II

Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 -

Name: Z-3012-2020 Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 -
Creator: Irvine Biomedical Inc, a St. Jude Medical Co.
Published: 2020-08-24
License: https://open.fda.gov/license/

Irvine Biomedical. Inc. / initiated 2020-08-24 / Terminated / root cause: labeling and UDI

FDA source

Irvine Biomedical Inc, a St. Jude Medical Co. began a recall of Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters... on 2020-08-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3012-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-24
Posted: 2020-09-24
Terminated: 2023-07-31
Recalling firm: Irvine Biomedical. Inc.
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.
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
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
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On 08/24/2020, Abbott Urgent Medical Device Recall Notices started being distributed to consignees in person or via mail. Customers were advised to do the following: 1) Any remaining inventory from this affected lot should not be used. 2) Complete and return the Acknowledgment Form. 3) Return any remaining unused affected devices. Please pass this notice to all those who need to be aware of it within your organization and maintain a record of this notice along with a copy of the completed Acknowledgement Form to ensure effectiveness of this communication. Should you have questions about this issue or for order replenishment, please contact your local firm Representative or Support at 1-855-478-5833 (Option 1) (U.S.), 7:00 a.m. - 7:00 p.m. Central Time, Monday through Friday.
Quantity in commerce: 40 units
Distribution: Worldwide distribution - U.S. Nationwide distribution including the states of MO, IN, WI, TX, AZ, MI, VA, KY and the country of Japan.
Product codes and lots: GTIN: 05414734309936, Lot: 7397307

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3012-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3011-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-24
Z-3012-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-24

Product code DRF

K961924Class IIIbi-1100 Steerable Electrophysiology Catheter SystemIrvine Biomedical, Inc. / cleared 1997-04-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)