Arrow Berman Angiographic Catheter Recall Due to Outdated Contrast Medium Labeling
Arrow International is recalling Berman Angiographic Catheters because the instructions reference a discontinued contrast medium. The firm is updating the labeling.
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: This is a Class II recall involving a labeling error where the instructions reference a discontinued product. It is a voluntary precautionary recall to update documentation, with no reported injuries or illnesses.
Plain-English summary
Arrow International Inc. is recalling the Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The recall involves 99,627 units distributed worldwide, including the United States and numerous international countries. The specific part numbers affected are AI-07035, AI-07131, AI-07135, AI-07037, AI-07132, AI-07136, AI-07130, AI-07133, AI-07137, AI-07130-J, AI-07134, and AI-07138.
The reason for the recall is that the product specifications sheet, which is part of the Instructions for Use (IFU), references Renografin-76 contrast medium. This specific contrast medium, with a viscosity of 8.4 centipoise, is no longer available. The firm is currently in the process of updating the labeling for these products to reflect current availability.
Health care providers using these catheters are instructed to select an alternative contrast medium when the specified Renografin-76 is not available. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 99,627
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 (12)
- Part Numbers --AI-07035
- AI-07131
- AI-07135
- AI-07037
- AI-07132
- AI-07136
- AI-07130
- AI-07133
- AI-07137
- AI-07130-J
- AI-07134
- AND AI-07138.
Distribution
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