--- title: "Datascope Corporation Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Datascope Corporation recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/datascope-corporation/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Datascope Corporation recall records **4** reported ongoing 4 records in this archive. Latest source date Aug 5, 2022. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Aug 5, 2022 FDA device enforcement ### [LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.](https://isitonrecall.com/recall/fda-device-z-0131-2023-linear-7-5fr-40cc-iab-with-accessories-apa-model-no-0684-00-0480-02-intra-aortic-balloon-catheter/) The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients wh... Class II Reported ongoing Distribution: No US distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Columbia, Ecuador, Egypt, France, Indonesia, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Nether... [Official source for LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon ca...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0131-2023%22) Aug 5, 2022 FDA device enforcement ### [MEGA 8Fr 50cc Intra-Aortic Balloon Catheter](https://isitonrecall.com/recall/fda-device-z-1685-2022-mega-8fr-50cc-intra-aortic-balloon-catheter/) Certain lots containing undersized dilator. Class II Reported ongoing Distribution: Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Polan... [Official source for MEGA 8Fr 50cc Intra-Aortic Balloon Catheter](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1685-2022%22) Aug 5, 2022 FDA device enforcement ### [Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter](https://isitonrecall.com/recall/fda-device-z-1686-2022-sensation-plus-8fr-50cc-intra-aortic-balloon-catheter/) Certain lots containing undersized dilator. Class II Reported ongoing Distribution: Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Polan... [Official source for Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1686-2022%22) Aug 5, 2022 FDA device enforcement ### [Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter](https://isitonrecall.com/recall/fda-device-z-1687-2022-insertion-kit-for-use-with-sensation-plus-8f-50cc-intra-aortic-balloon-catheter/) Certain lots containing undersized dilator. Class II Reported ongoing Distribution: Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Polan... [Official source for Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1687-2022%22) ## Reasons in these listed records - The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynam... - Certain lots containing undersized dilator. These examples come from this result page and are not a ranking of every recall reason. ## Checking Datascope Corporation ### Is there a recall on datascope corporation right now? This archive contains 4 records, including 4 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Datascope Corporation](https://isitonrecall.com/check/?q=Datascope%20Corporation) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)