Covidien Chameleon PTA Balloon Catheter Recalled for Failed Pressure Testing
Covidien is recalling specific lots of its Chameleon PTA Balloon Catheter that failed in-house pressure testing. The affected catheters were distributed worldwide to the US and 18 countries.
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: FDA Class II medical device with documented quality failure (pressure test failure) that poses risk during vascular procedures. No injuries reported in source text, placing this at 'risk-of-harm product without reported injury' per the rubric.
Plain-English summary
Covidien LP is recalling specific lots of the Chameleon PTA Balloon Catheter with Injection Port, a medical device used in percutaneous transluminal angioplasty (PTA) procedures. The affected product is available in seven size configurations, ranging from 5mm to 12mm in diameter, with a total of approximately 16,336 units being recalled.
The specific lots were recalled because they failed to meet Covidien's in-house balloon pressure testing specifications. A balloon catheter that fails pressure testing may not function as intended during medical use.
The recalled catheters were distributed worldwide to the United States and 18 foreign countries, including Austria, Canada, China, France, Germany, India, Israel, Italy, Japan, Netherlands, Singapore, Spain, and Turkey. The FDA classified this as a Class II recall.
The recalled product
- Product
- Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US)…
- Manufacturer
- Covidien LP
- Affected units
- 16,336
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)
- 1. 5mm x 40mm x 75cm (CFN CH05-40-75US): UDI-DI: 10884521812260
- Lot Numbers: 22201047
- 22201424
- 22201425
- 22202802
- 22203008
- 22203009
- 22203040
- 22300536
- 22300970
- 22300971
- 22301116
- 22301270
- 22400129
- 22400572
- 22400573
- Added 12/13/2024: 22202643
- 22300000
- 22300969
- 22301117. Expansion 12/05/2024 with additional serial numbers: 22202643
Distribution
Distributed nationwide across the United States.
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