Datascope SENSATION PLUS Intra-Aortic Balloon Catheter Dilator Fracture Risk
Datascope's SENSATION PLUS intra-aortic balloon catheter dilator may fracture during insertion, potentially damaging the femoral artery or aorta. The firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source reports one patient death resulting from dilator fracture complications. Per the severity rubric, reported deaths trigger a Critical rating regardless of other factors.
Plain-English summary
Datascope Corp. is recalling the SENSATION PLUS 7.5Fr intra-aortic balloon catheter and accessories, used to provide counter-pulsation therapy in the aorta. Approximately 321,609 units have been distributed nationwide in the United States and internationally worldwide.
During device insertion, the introducer dilator may fracture at the hub. When this occurs, the body of the dilator can remain lodged within the sheath. This defect creates risk of damage to the femoral artery, damage to the descending aorta, embolization, surgical intervention requirements, and delay of intra-aortic balloon therapy.
Datascope has received 10 complaints related to this issue, including 3 serious adverse events and 1 patient death. Healthcare facilities should contact Datascope for further information about this recall and any corrective actions.
The recalled product
- Product
- SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 7.5Fr.…
- Manufacturer
- Datascope Corp.
- Affected units
- 321,609
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Datascope Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Same hazard · dilator fracture
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