Irvine Biomedical, A St. Jude Medical Company
Country not established
- Devices
- 2
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Irvine Biomedical, A St. Jude Medical Company makes
Irvine Biomedical manufactures the ViewFlex Xtra ICE Catheter, a diagnostic device used for intracardiac echocardiography (ICE) to visualize cardiac structures during procedures.
The ViewFlex Xtra ICE Catheter is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Viewflex Xtra Ice Catheter Ref K133853
Regimes: 510(k) Registry: 510(k)ViewFlex Xtra ICE Catheter Ref K223077
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Irvine Biomedical, A St. Jude Medical Company, initiated on 2020-08-24. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 2
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 24 Aug 2020 Z-3011-2020 Class II Terminated 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
Full distribution text
- 24 Aug 2020 Z-3012-2020 Class II Terminated 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
Full distribution text
- 24 Aug 2020 Z-3011-2020 Class II Terminated 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
Frequently asked questions
How many devices does Irvine Biomedical, A St. Jude Medical Company have in the registry?
The registry currently lists 2 devices for Irvine Biomedical, A St. Jude Medical Company. Devices recorded under merged duplicate company entries are counted once.
Which registries list Irvine Biomedical, A St. Jude Medical Company's devices?
Among its 2 most recently registered devices, Irvine Biomedical, A St. Jude Medical Company has devices listed in FDA 510(k) (2 devices).
What risk classes do Irvine Biomedical, A St. Jude Medical Company's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Irvine Biomedical, A St. Jude Medical Company's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Irvine Biomedical, A St. Jude Medical Company?
FDA recall records list 2 recalls initiated by Irvine Biomedical, A St. Jude Medical Company, the most recent initiated on 24 Aug 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Irvine Biomedical, A St. Jude Medical Company in the registry?
The most recently registered devices listed for Irvine Biomedical, A St. Jude Medical Company include VIEWFLEX XTRA ICE CATHETER.