Datascope SENSATION 7 Intra-Aortic Balloon Catheters Recalled for Introducer Fracture Risk
The SENSATION 7 Fr. intra-aortic balloon catheter introducer dilator may fracture during insertion, potentially damaging blood vessels and requiring surgery. One death has been reported among 10 total complaints.
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: FDA Class II recall with a reported patient death and 3 serious adverse events. Per the severity rubric, the presence of reported fatalities results in a score of 5 regardless of other factors.
Plain-English summary
Datascope Corp. is recalling SENSATION 7 Fr. Intra-Aortic Balloon (IAB) Catheters and Accessories used for cardiac counterpulsation therapy. The recall encompasses multiple variants manufactured across multiple countries, totaling 321,609 units distributed domestically and worldwide.
During insertion, the introducer dilator may fracture at the hub, potentially leaving fragments inside the catheter sheath. This can damage the femoral artery or descending aorta, cause blood clots (embolization), or require emergency surgical repair and delay necessary cardiac therapy.
Datascope has documented 10 complaints, including 3 serious adverse events and 1 patient death. Healthcare facilities should immediately cease using affected devices and contact the manufacturer for guidance. Patients who have already received these catheters should discuss their individual situation with their cardiologist or healthcare provider.
The recalled product
- Product
- SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA
- Manufacturer
- Datascope Corp.
- Category
- Medical Device — Cardiac Support
- Hazard
- introducer-fracture
- arterial-injury
- embolization
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- US ONLY 10607567109558 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES
Distribution
Distributed nationwide across the United States.
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