FDA Medical Device Recalls (openFDA)
Irvine Biomedical Inc, a St. Jude Medical Co.: 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 the high right atrium, right ventricular apex, and HIS bundle.
- Recall number
- Z-3011-2020
- Recalling firm
- Irvine Biomedical Inc, a St. Jude Medical Co.
- Product
- 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 the high right atrium, right ventricular apex, and HIS bundle.
- Status
- Terminated
- Initiated
- 2020-08-24
- Posted
- not on file
- Terminated
- 2023-07-31
- 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
- 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
- 15 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.
- Lot, serial or model codes
- GTIN: 05414734302975, Lot: 7397352
- 510(k) numbers
- ["K961924"]
- PMA numbers
- not on file
- Product code
- DRF
- Firm FEI
- 1000519796
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28