The Recall Desk
CriticalFDA (Devices)·Z-2221-2023·Announced 2023-08-02

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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. 40c
Manufacturer
Datascope Corp.
Category
Medical Device — Intra-Aortic Balloon Catheter
Hazard
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.

See all 9 products in this recall →

Related recalls

Same manufacturer · Datascope Corp.

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Same hazard · dilator fracture

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