Cordis POWERFLEX PRO PTA Dilatation Catheter Recall for Unsterilized Unit
Cordis Corporation is recalling one unsterilized unit of the POWERFLEX PRO PTA Dilatation Catheter from a demonstration lot left at a hospital.
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 3/5 (High).
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: The recall involves a medical device that was not sterilized, presenting a risk of harm (infection) even though no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Cordis Corporation is recalling one unit of the POWERFLEX PRO PTA Dilatation Catheter. The device is intended to dilate stenoses in various arteries and for the treatment of obstructive lesions in arteriovenous dialysis fistulae.
The recall was initiated because one unit from a demonstration lot was left at a hospital and was not sterilized. The specific unit is identified by Catalog 4400615X and demo lot 15617883.
The recall involves a nationwide distribution across the United States, including the District of Columbia and Hawaii. Consumers and healthcare providers should stop using the affected unit and contact Cordis Corporation for further instructions.
The recalled product
- Product
- Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also…
- Manufacturer
- Cordis Corporation
- Category
- Medical Device — Catheter
- Affected units
- 120
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)
- Catalog 4400615X
- demo lot 15617883
Distribution
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