Ultra IABP catheter kits carry indications not reviewed by the FDA
Insightra Ultra IABP Catheter Kits are being recalled because the device carries indications and compatibility claims not reviewed by the FDA, and its instructions are inconsistent with product training.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall over unapproved labeling claims and inconsistent instructions, with no device defect or clinical consequence stated.
Plain-English summary
The Ultra IABP Catheter Kit, catalog numbers IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25 and IMU7F-20, is being recalled across all lots. The action covers 24,227 units.
The stated reason is that the device contains indications for use and device compatibility claims that have not been reviewed and approved for safety and effectiveness by the FDA, and that the instructions for use are not consistent with product training. The FDA classified the action as Class II. The source does not describe a device defect or resulting clinical consequence.
Distribution was worldwide, including nationwide in the United States in Texas, Missouri, Florida and Michigan among other states. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog numbers and UDI codes above and follow the instructions issued by the manufacturer.
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…
- Manufacturer
- Insightra Medical Inc
- Affected units
- 24,227
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
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