MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 30
FDA device recall Z-1701-2018 · posted 2018-05-16 · Terminated
Recall details
- Recalling firm
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Reason for recall
- There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.
- Action taken
- The firm initiated their recall via an Urgent Medical Device Recall letter, dated February 26, 2018. The letter identified the affected device, described the issue, product scope, and the actions to be taken. The firm recommended users remove and quarantine all affected and unexpired product in their inventory and return the affected products to Medtronic. Customers may contact their Medtronic representative if alternative product is needed. The Customer Confirmation Form should be completed and faxed to Medtronic at 1-949-434-5020, to the attention of Neurovascular Quality.
- Root cause
- Process design
- Status
- Terminated
- Product code
- NRY
- Quantity affected
- 1,942 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2018-02-26
- Date posted
- 2018-05-16
- Date terminated
- 2021-09-30
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE (K141516) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015-02-05 |