Intra-Aortic Balloon Catheter Introducer Dilator May Fracture During Insertion
Datascope TRANS-RAY IAB catheters may have introducer dilators that fracture during insertion, risking arterial damage or blood clots. The firm reports 1 death and 3 serious injuries.
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 1 patient death, which per FDA criteria constitutes a Critical-severity recall (score 5). Additionally, 3 serious adverse events have been reported.
Plain-English summary
The TRANS-RAY IAB (Intra-Aortic Balloon Catheter) and accessories, manufactured by Datascope Corp., are being recalled due to a defect in the introducer dilator. During catheter insertion, the introducer dilator may fracture at the hub, and the fractured portion may remain inside the sheath.
This defect presents serious health risks. The fractured dilator can damage the femoral artery, descending aorta, or cause embolization. Patients may require surgical intervention and experience delays in IAB therapy. Datascope has received 10 complaints about this issue, including 3 serious adverse events and 1 patient death.
The recall affects approximately 321,609 kits distributed nationwide in the United States and internationally. Healthcare providers should contact the manufacturer for information about affected units and appropriate actions.
The recalled product
- Product
- TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR. 4
- Manufacturer
- Datascope Corp.
- Category
- Medical Device — Cardiovascular
- Hazard
- fracture
- arterial-injury
- embolization
Distribution
Distributed nationwide across the United States.
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