Cordis POWERFLEX PRO PTA Dilatation Catheter Recalled for Burst Strength Failure
Cordis Corporation is recalling 162 units of POWERFLEX PRO PTA Dilatation Catheters because they may not meet internal manufacturing burst strength specifications.
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 is classified as FDA Class II, and the hazard involves a structural failure (burst strength) of a medical device used in vascular procedures, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Cordis Corporation is recalling 162 units of the POWERFLEX PRO PTA Dilatation Catheter. The recall is due to a potential failure to meet the internal manufacturing shaft subassembly burst strength specification, specifically a failure of the Burst Shaft Test.
The affected devices are intended to dilate stenoses in various arteries and for the treatment of obstructive lesions in arteriovenous dialysis fistulae. The recall covers 74 units distributed in the United States and 88 units distributed in Japan and the Netherlands. The specific catalog numbers, lot numbers, and expiry dates for the affected units are listed in the official recall documentation.
Healthcare providers and patients should stop using the affected devices and contact Cordis Corporation for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is 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…
- Manufacturer
- Cordis Corporation
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 (4)
- 4400602S 82144141 2020-05-31
- 4400515X 82144947 2020-06-30
- 4400308S 82148810 2020-11-30
- and 4400508S 82148811 2020-11-30.
Distribution
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