Reinforced Introducer SET recall
REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description…
Why was Reinforced Introducer SET recalled?
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Description UDI REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr. 10607567106656 REINFORCED INTRODUCER SET FOR SENSATION 7Fr. 10607567106694 REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr. 10607567107943
- Product
- REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description…
- Recalling firm
- Datascope Corp.
- Quantity
- 321,609 total kits
- Distribution
- Domestic distribution nationwide. International distribution worldwide.
- Recall date
- August 2, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)