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), 12mm x 40mm x 75cm (CFN CH12-40-75US)
This recall is currently active, issued October 29, 2024.
- Recall Initiated
- September 19, 2024
- Posted
- October 29, 2024
- Recall Number
- Z-0257-2025
- Quantity
- 16,336 units
- Firm Location
- Mansfield, MA
- Official Source
- View on FDA website ↗
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.
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 Numbers: 22201814, 22201871, 22202646, 22300185, 22300219, 22300231, 22300863, 22301300, 22301301, 22302026, 22302031, 22302044, 22400153, 22400247, Added 12/13/2024: 22200739, 22201815, 22202176, 22202177, 22202799. Expansion 12/05/2024 with additional serial numbers: 22200739, 22201815, 22202176, 22202177, 22202799. 7. 12mm x 40mm x 75cm (CFN CH12-40-75US): UDI-DI: 10884521812321; Lot Numbers: 22201391, 22201872, 22202781, 22300301, 22300302, 22300878, 22300967, 22300968, 22301269, 22400128, 22400279, Added 12/13/2024: 22202212, 22202213, 22203025, 22300300. Expansion 12/05/2024 with additional serial numbers: 22202212, 22202213, 22203025, 22300300.
Root Cause
Under Investigation by firm
Action Taken
An "URGENT: MEDICAL DEVICE RECALL" notification letter dated September 2024 was sent to customers. Required Actions: 1. Quarantine and discontinue use of unused affected product lot numbers immediately (see Attachment A). 2. Return all unused products from your inventory to Medtronic. Please contact: rs.covidienfeedbackcustomerservice@medtronic.com for the Return Good Authorization (RGA). a. Credit for the returned affected product will be issued based on the RGA number. b. If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. 3. Complete and return the enclosed Consignee Confirmation Product Retrieval to rs.gmbmitgfca@medtronic.com even if you do not have unused inventory. Please copy your local sales representative on this email when possible. 4. Share this notice with those who need to be aware within your organization or to any organization including, but not limited to, surgeons, interventionalists, or other staff. Please maintain a copy of this notice in your records. If you have questions regarding this communication, please contact your local representative or Customer Service at 800-962-9888, option 2 (Monday Friday 8:00 a.m. to 6:30 p.m.).