Recall Z-3011-2020 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
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.
| Date | Aug 24, 2020 |
| Status | Terminated |
| 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 t |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961924 | IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM Irvine Biomedical, Inc., Apr 11, 1997 |