Recall Z-2761-2017 ยท JCT Prosthesis, Tracheal, Expandable
Atrium Medical Corporation
Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
| Date | Jul 7, 2017 (initiated May 25, 2017) |
| Status | Terminated |
| Reason | Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x 38 mm x 80 cm. The complaint was the result of incorrect dimensional information (7mm x 38mm x 80cm) printed on the manifiold (catheter hub). The complaint device physical dimensions matched the dimensional information displayed on the outer packaging and the device inner pouch. This was the only complaint received for this non-conformance. |
| Root cause | Under Investigation by firm |
| Action | The firm, Getinge/Maquet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated May 25, 2017 via FedEx overnight to affected US consignees via FedEx Next Day Air. Getinge sent a second "URGENT MEDICAL DEVICE RECALL LETTER" dated June 2, 2017 via FedEx overnight to the affected customers in order to correct a product code/part number due to a typo in the initial letter and to assist in identifying the labeling problem. The letters described the product, problem and actions to be taken. Customers are instructed to examine your inventory; remove affected products; quarantine and place in a secure |
| Quantity | 246 (US: 183 units; Foreign: 63 units) |
| Distribution | Worldwide distribution-US (nationwide) and countries of: Germany, Great Britain, Austria, Ireland, Netherlands, France, Italy, Sweden, and San Marino. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050814 | ATRIUM ICAST COVERED STENT Atrium Medical Corp., May 6, 2005 |