Cordis SABER PTA Balloon Catheter Recalled for Foreign Material Contamination
Cordis Corporation is recalling the SABER PTA Balloon Dilation Catheter due to potential contamination with foreign material from manufacturing. The contamination may transfer from the protective sheath to the balloon itself.
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: This is an FDA Class II recall of a medical device used in vascular intervention. While no illnesses or injuries are mentioned in the source, the product is a risk-of-harm device—a contaminated balloon catheter could malfunction during use, potentially causing vessel damage or other complications.
Plain-English summary
Cordis Corporation is recalling the SABER PTA Balloon Dilation Catheter, 4F (model 48004010X), due to a potential manufacturing defect. The balloon protective sheath may be contaminated with foreign material left over from the manufacturing process.
The contamination may potentially transfer from the protective sheath to the balloon. This defect could affect device performance during clinical use.
The affected product was lot 82219442. Distribution included the United States (California and Ohio) as well as Switzerland, Portugal, and Poland. Eight units were distributed.
Healthcare providers and facilities that received these catheters should not use this lot. Contact Cordis Corporation to arrange for replacement or return of the recalled units.
The recalled product
- Product
- Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
- Manufacturer
- Cordis Corporation
- Affected units
- 8
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)
- Lot/Batch number 82219442
Distribution
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