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.
What this means for you
Illness, injury, or structural failure has been reported. 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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