Ultra IABP Catheter Kit recalled for unapproved indications and inconsistent instructions
Insightra Medical is recalling the Ultra IABP Catheter Kit because the device contains indications for use and compatibility claims that were not reviewed and approved by the FDA, and the instructions for use do not match product training.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a high-risk cardiac device with unapproved indications for use and inconsistent instructions that could lead to improper clinical use. While no illnesses or injuries have been reported, the risk of harm from potential misuse of a cardiac assist device without approved indications is significant.
Plain-English summary
Insightra Medical Inc is recalling the Ultra IABP Catheter Kit (models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20) due to regulatory compliance issues. The device contains indications for use and device compatibility claims that have not been reviewed and approved for safety and effectiveness by the FDA. The instructions for use are also not consistent with the product training provided.
The Ultra IABP Catheter Kit is a 7 French cardiac assist catheter designed for counterpulsation therapy in clinical cardiac support. The device is packaged with accessories including guide wires, syringes, and pressure tubing.
The recall affects 24,227 units distributed nationwide in Texas, Missouri, Florida, and Michigan, and internationally in Albania, Azerbaijan, Bangladesh, Brazil, Cambodia, Colombia, Hong Kong, India, Indonesia, Iran, Israel, Saudi Arabia, Kuwait, Lebanon, Malaysia, Nepal, Oman, Pakistan, Peru, Romania, Russia, Serbia, Singapore, and the United Arab Emirates.
Healthcare providers with questions about this recall should contact Insightra Medical Inc.
The recalled product
- Product
- Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available wi
- Manufacturer
- Insightra Medical Inc
- Hazard
- unapproved-indications
- instruction-inconsistency
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 (5)
- Lot code: All lots / UDI: IMU7F-40: 00850012832546
- IMU7F-35: 00850012832515
- IMU7F-30: 00850012832485
- IMU7F-25: None
- IMU7F-20: None
Distribution
Distributed nationwide across the United States.
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