Reported Feb 9, 2022 · Ongoing
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm;…
Covidien LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien Llc · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
- 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
- Lot codes and dates
- UDI
108845218122530729001674504710884521812291
- For CFN CH08-40-75USGTIN Batch
0729001674504721904374072900167450472190443207290016745047220006730729001674504722000709072900167450472200081707290016745047220008800729001674504722001030072900167450472200106107290016745047220011910729001674504722001310072900167450472200141707290016745047220014480729001674504722001728072900167450472200208607290016745047220020881088452181225322002498072900167450472200258310884521812253220026030729001674504722003037072900167450472210000307290016745047221003210729001674504722100322072900167450472210108907290016745047221010901088452181229122102189
- UDI
- Amount recalled
- 1,994 devices
Where it was sold
- Nationwide
Why it was recalled
The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks associated with surgical intervention, or delay to treatment/therapy.
This product could cause temporary or reversible health problems — stop using it.
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