Cordis EMPIRA NC RX PTCA Dilatation Catheter Recalled for Balloon Defect
Cordis Corporation is recalling 250,000 EMPIRA NC RX PTCA Dilatation Catheters because the balloon cover may be difficult to remove, potentially causing the balloon to burst or the shaft to separate during use.
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 defect that could result in vessel trauma or surgery, which fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Cordis Corporation is recalling 250,000 units of the EMPIRA NC RX PTCA Dilatation Catheter. The recall covers 63 specific catalog numbers, including 75R06200N and 75R25400N. The affected devices were distributed worldwide, including in the United States, Puerto Rico, and several countries in the Americas.
The recall was initiated because the balloon on the catheter may exhibit resistance when the balloon cover is being removed. If excessive force is applied to remove the cover, the product may weaken in the region of the proximal balloon seal. This weakening can lead to the balloon bursting, the shaft separating, or difficulties with deflation.
These mechanical failures could result in procedural delays, vessel trauma, or the need for surgery. The source text does not report any specific injuries or illnesses associated with this defect. Healthcare providers and patients should contact Cordis Corporation for further instructions on how to handle the affected devices.
The recalled product
- Product
- Cordis EMPIRA NC RX PTCA Dilatation Catheter
- Manufacturer
- Cordis Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 250,000
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 (20)
- 63 Catalog numbers: 75R06200N
- 75R06225N
- 75R06250N
- 75R06275N
- 75R06300N
- 75R06325N
- 75R06350N
- 75R06375N
- 75R06400N
- 75R10200N
- 75R10225N
- 75R10250N
- 75R10275N
- 75R10300N
- 75R10325N
- 75R10350N
- 75R10375N
- 75R10400N
- 75R12200N
- 75R12225N
Distribution
Part of a larger recall action
This product is one of 2 recalled by Cordis Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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