Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-
FDA device recall Z-0257-2025 · posted 2024-10-29 · Open, Classified
Recall details
- Recalling firm
- Covidien LP
- Reason for recall
- Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
- 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.).
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LIT
- Quantity affected
- 16,336 units
- 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, Ja
- Date initiated
- 2024-09-19
- Date posted
- 2024-10-29
- Location
- Mansfield, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Chameleon PTA Balloon Catheter (K163231) | Av Medical Technologies, Ltd. | 2017-01-17 |