The Recall Desk
Agency classClass IIOur severity:CriticalFDA (Devices)·Z-2219-2023·Announced 2023-08-02

Intra-Aortic Balloon Catheter kits recalled due to dilator fracture risk

Datascope's MEGA 7.5Fr. intra-aortic balloon catheter kits may have introducers that fracture during insertion, risking arterial damage and embolization. The firm has received 10 complaints including 3 serious events and 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: The rubric mandates a Critical (score 5) designation whenever reported deaths exist in the source text, regardless of other factors. This recall confirms 1 patient death, meeting the criteria for the highest severity level.

Plain-English summary

Datascope Corp. is recalling MEGA 7.5Fr. intra-aortic balloon (IAB) catheter kits used to deliver counter-pulsation therapy in the aorta. Affected products include multiple part numbers and configurations distributed domestically nationwide and internationally worldwide, totaling 321,609 kits.

The introducer dilator component may fracture at the hub during catheter insertion, leaving fragments of the dilator housed within the sheath. This defect can cause damage to the femoral artery, descending aorta, or embolization, potentially requiring emergency surgical intervention and delaying critical IAB therapy.

Datascope has received 10 complaints, including 3 serious adverse events and 1 reported death. The FDA classified this as a Class II recall. Patients and healthcare providers should immediately contact Datascope Corp. for guidance on handling affected kits and obtaining replacements.

The recalled product

Product
MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH…
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Catheter
Hazard
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 10605767109596 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES APA
  • US ONLY 10607567109572 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES APA

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 →

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