Intra-aortic balloon catheter recall due to introducer dilator fracture risk
Datascope Corp. is recalling SENSATION PLUS 8Fr. intra-aortic balloon catheters because the introducer dilator may fracture during insertion, risking blood vessel damage and surgical intervention. The company received 10 complaints, including 1 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 rubric requires a Critical (5) score when reported deaths exist, regardless of other factors. The source confirms 1 patient death. Additionally, 3 serious adverse events and the risk of arterial damage requiring surgical intervention support this critical rating.
Plain-English summary
Datascope Corp. is recalling SENSATION PLUS 8Fr. 50cc intra-aortic balloon catheters and associated accessories. The product is used to deliver counter-pulsation therapy in the aorta during cardiac care.
During catheter insertion, the introducer dilator may fracture at the hub, leaving the broken piece housed within the patient's vascular sheath. This defect can cause damage to the femoral artery, descending aorta, or embolization. Surgical intervention and delays in therapy may result.
The product has been distributed nationwide in the United States and worldwide internationally. Datascope has received 10 complaints related to this defect, including 3 serious adverse events and 1 patient death.
The recalled product
- Product
- SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 8Fr. 50cc…
- 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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