Covidien LP: 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

Hazard

Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.

Details from the source

Reason for recall: Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. Distribution: Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Canada, Canary Islands, China, France, French Guiana, Germany, Greece, Guadeloupe, India, Ireland, Israel, Italy, Japan, Netherlands, Portugal, Singapore, Spain and Turkey. Quantity: 16,336 units Lot/code info: 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, 22300000, 22300969, 22301117. 2. 6mm x 40mm x 75cm (CFN CH06-40-75US): UDI-DI: 10884521812277; Lot Numbers: 22201337, 22201908, 22202412, 22202413, 22202611, 22202612, 22202801, 22300151, 22300318, 22300319, 22300320, 22300862, 22300965, 22301285, 22301494, 22301661, 22301895, 22301896, 22302180, 22400243, 22400244, 22400574, 22400576. 3. 7mm x 40mm x 75cm (CFN CH07-40-75US): UDI-DI: 10884521812284; Lot Numbers: 22200635, 22201897, 22202223, 22202426, 22202427, 22202800, 22203055, 22300321, 22300864, 22301028, 22301648, 22301649, 22301889, 22301890, 22302033, 22302034. 4. 8mm x 40mm x 75cm (CFN CH08-40-75US): UDI-DI: 10884521812291; Lot Numbers: 22201015, 22201046, 22201087, 22201785, 22201786, 22201813, 22202144, 22202145, 22202644, 22202645, 22300165, 22300230, 22300534, 22300535, 22300876, 22300877, 22300966, 22301133, 22301134, 22301299, 22301495, 22302032, 22400154, 22400164, 22400165. 5. 9mm x 40mm x 75cm (CFN CH09-40-75US): UDI-DI: 10884521812307; Lot Numbers: 22201364, 22202428, 22203026, 22300152, 22300539, 22301123, 22301124, 22400698, 22400699, 22400858. 6. 10mm x 40mm x 75cm (CFN CH10-40-75US): UDI-DI: 10884521812314; Lot

UPC codes

10884521812260, 10884521812277, 10884521812284, 10884521812291, 10884521812307, 10884521812314, 10884521812321

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.