Chameleon PTA Balloon Catheter difficult protector sleeve removal risk
The Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm has a protector sleeve that may be difficult to remove, potentially damaging the balloon and causing patient harm. Covidien is recalling 1,994 devices.
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 recall with potential to cause serious harm (vessel perforation, embolism, surgical complications), but the source describes the hazard as theoretical ('may potentially occur') with no reported illnesses or injuries. Per the severity rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Covidien is recalling the Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm (product numbers CH08-40-75GB and CH08-40-75US), a cardiovascular catheter. The recall affects 1,994 devices distributed worldwide.
The company has received six complaints indicating difficulty removing the balloon protector sleeve from the catheter. In some cases, excessive force is required. If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a procedure, potential patient harm may occur, including perforation of vessels, foreign body, embolism, surgical intervention complications, or delayed treatment.
The affected devices have been distributed in the US and internationally in Germany, Israel, Italy, Portugal, Spain, Chile, Singapore, and China.
The recalled product
- Product
- Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
- Manufacturer
- Covidien Llc
- Category
- Medical Device — Cardiovascular
- Affected units
- 1,994
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 (2)
- UDI: 10884521812253
- 07290016745047
Distribution
Distributed nationwide across the United States.
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