Cordis EMPIRA RX PTCA Dilatation Catheter Recalled for Potential Bursting
Cordis Corporation is recalling 80 units of EMPIRA RX PTCA Dilatation Catheters because they may exhibit radial versus axial tears if they burst during inflation.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that could cause significant injury if the catheter bursts during use.
Plain-English summary
Cordis Corporation is recalling 80 units of the EMPIRA RX PTCA Dilatation Catheter, Catalog # 85R30300S, for cardiovascular use. The recall involves Lot # CE0001447 with an expiration date of 2014-08.
The recall was initiated because the dilatation catheters could exhibit radial versus axial tears should they burst during inflation. This defect poses a risk of injury to patients during the procedure.
The affected units were distributed worldwide, including in the United States (AZ, FL, IL, LA, MA, NJ, OR, SC, and TX) and numerous international locations such as Armenia, Austria, Belgium, and others. Healthcare providers and consumers should stop using the affected devices and contact Cordis Corporation for further instructions.
The recalled product
- Product
- Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
- Manufacturer
- Cordis Corporation
- Affected units
- 80
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 (1)
- Catalog # 85R30300S LOT # CE0001447 exp date: 2014-08
Distribution
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