LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Check against the official notice below — it lists the full affected range.
Datascope Corporation is recalling the LINEAR 7.5Fr. 40cc intra-aortic balloon catheter with accessories due to a labeling error on one of three internal hospital-use labels. The balloon volume is incorrectly marked as 34cc instead of the correct 40cc, which could confuse users and delay therapy initiation. Such delays in treatment could negatively affect patients with unstable hemodynamics.
The recalled devices were distributed outside the United States to 24 countries including Canada, Mexico, the United Kingdom, and various nations in South America, Europe, the Middle East, Africa, and Asia. A total of 4,414 units were affected across multiple lot codes. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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 hemodynamically unstable.
Reason for recall: 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 hemodynamically unstable. Distribution: No US distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Columbia, Ecuador, Egypt, France, Indonesia, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Pakistan, Poland, Portugal, South Korea, Russia, Spain, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay. Quantity: 4414 OUS Lot/code info: UDI-DI: 10607567106571 Lot codes: 3000210759 3000210758 3000203002 3000198455 3000144227 3000142368 3000141069 3000140532 3000134522 3000130423 3000126591
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.