LINEAR intra-aortic balloon catheter introducer dilator fracture risk
Datascope's LINEAR intra-aortic balloon catheters may develop a fractured introducer dilator that can injure blood vessels or cause dangerous blockages. The company has received 10 complaints including 1 death and 3 serious adverse events.
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 source explicitly reports 1 patient death. Per the severity rubric, reported deaths result in a Critical (5) score regardless of other factors.
Plain-English summary
Datascope Corp. has recalled LINEAR 7.5Fr. intra-aortic balloon (IAB) catheters and accessories used to provide counter-pulsation therapy in the aorta. The recall affects 321,609 total kits distributed domestically within the United States and internationally worldwide.
During insertion, the introducer dilator may fracture at the hub, leaving the body of the dilator within the sheath. This fracture can cause damage to the femoral artery or descending aorta, result in embolization, and may necessitate surgical intervention and delay of intra-aortic balloon therapy.
Datascope has received 10 complaints associated with this problem, including 3 serious adverse events and 1 reported patient death.
The recalled product
- Product
- LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number LINEAR 7.5Fr. 34cc IAB WITH…
- Manufacturer
- Datascope Corp.
- Affected units
- 321,609
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 (2)
- US ONLY 10605767109503 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES
- US ONLY 10607567109527 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES
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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