LINEAR Intra-Aortic Balloon Catheter Recalled for Incorrect Volume Labeling
Datascope's LINEAR intra-aortic balloon catheter has an incorrect balloon volume label on internal instructions that may delay critical therapy in unstable patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a critical medical device with a labeling error that could delay therapy initiation in hemodynamically unstable patients. While no illnesses or injuries have been reported, the source describes potential for serious harm in this high-risk population, fitting the rubric criterion for Score 3: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Datascope Corporation is recalling the LINEAR 7.5Fr. 40cc intra-aortic balloon catheter (Model No. 0684-00-0480-02). The device contains a labeling error on one of three internal labels provided for hospital staff: the actual balloon volume of 40cc is incorrectly marked as 34cc. This discrepancy may cause confusion during use and potentially delay the initiation of therapy.
In patients who are hemodynamically unstable—those with severely compromised blood flow and cardiovascular function—delays in starting intra-aortic balloon therapy can have serious clinical consequences. The mislabeling of the balloon volume increases the risk of confusion that could lead to treatment delays in this critical patient population.
The recall affects 4,414 units distributed outside the United States, including to Argentina, Brazil, Canada, Chile, Colombia, Ecuador, Egypt, France, Indonesia, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Pakistan, Poland, Portugal, South Korea, Russia, Spain, Turkmenistan, United Arab Emirates, United Kingdom, and Uruguay. Healthcare facilities in these countries should review their stocks and protocols for this device.
Healthcare providers who use this device should verify the actual balloon volume specifications and contact Datascope Corporation with any questions or for replacement products.
The recalled product
- Product
- LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 4,414
Distribution
Distribution scope not specified by the agency.
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