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Chameleon recallZ-0257-2025 · Covidien LP · initiated Sep 19, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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: [email protected] 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 [email protected] 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.).

Recall details

Recall number
Z-0257-2025
Status
Open, Classified
Initiated by the company
Sep 19, 2024
Posted by the FDA
Oct 29, 2024
Recalling firm
Covidien LP
Quantity
16,336 units
Product code
LIT
FDA submissions
K163231
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.

Product description

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)

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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.

Devices named in this recall

7 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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