Intra-Aortic Balloon Catheter Introducer Set fracture causes vascular injury
Datascope Corp. recalls Reinforced Introducer Sets because the dilator may fracture during catheter insertion, risking arterial damage and embolization. One patient death has been reported.
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: This recall meets the Critical severity threshold because one patient death has been reported. Per the FDA severity rubric, reported deaths result in a Critical classification regardless of other factors.
Plain-English summary
Datascope Corp. is recalling approximately 321,609 Reinforced Introducer Sets used with Intra-Aortic Balloon (IAB) Catheters. During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the broken dilator inside the sheath. This risk applies to three models: the set for Linear 7.5Fr. and Mega 7.5Fr. catheters, the set for Sensation 7Fr. catheters, and the set for Sensation Plus and Mega 8Fr. catheters.
The fractured dilator can cause serious injury. Potential complications include damage to the femoral artery, damage to the descending aorta, or embolization (blood clots or material traveling through blood vessels). Patients may require emergency surgical intervention and experience delayed IAB therapy. Datascope has received 10 complaints related to this defect, including 3 serious adverse events and 1 patient death.
The recalled products were distributed domestically nationwide and internationally. Healthcare facilities and clinicians should immediately stop using these introducer sets and contact Datascope Corp. for instructions on obtaining replacement products or alternative solutions. Patients who have received or are scheduled for IAB catheter insertion should discuss the recall with their healthcare providers.
The recalled product
- Product
- REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SE
- Manufacturer
- Datascope Corp.
- Hazard
- dilator-fracture
- arterial-injury
- aortic-injury
- embolization
Distribution
Distributed nationwide across the United States.
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