MEGA Intra-Aortic Balloon Catheter Introducer Fracture Poses Arterial Injury Risk
Datascope's MEGA 8Fr. intra-aortic balloon catheter introducer may fracture during insertion, leaving fragments that can damage blood vessels. The firm has reported 10 complaints, including 1 death.
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: Severity score is 5 (Critical) because the source explicitly reports 1 patient death. Per the rubric, reported deaths result in a score of 5 regardless of other factors.
Plain-English summary
Datascope Corp. is recalling the MEGA 8Fr. intra-aortic balloon catheter and accessories. This medical device is used to provide counter-pulsation therapy in the aorta. Approximately 321,609 units are affected, distributed domestically throughout the United States and internationally worldwide.
During catheter insertion, the introducer dilator may fracture at the hub, causing the dilator body to remain inside the sheath. This fracture can lead to blood vessel damage, including injury to the femoral artery or descending aorta, or cause blood clots (embolization). The fracture may also necessitate emergency surgery and delay necessary heart treatment.
Datascope has received 10 complaints related to this defect, including 3 serious adverse events and 1 reported patient death.
Healthcare providers should immediately stop using affected devices and consult the official FDA recall notice for detailed information about affected product codes and next steps. Hospitals should contact Datascope and their supply chain to identify and quarantine affected units.
The recalled product
- Product
- MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK…
- 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 (1)
- US ONLY 10607567109619 MEGA 8Fr. 50cc 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.
See all 9 products in this recall →Related recalls
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