Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
FDA device recall Z-2432-2021 · posted 2021-09-15 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.
- Action taken
- The firm disseminated an Urgent Medical Device Field Correction notice beginning on 07/21/2021. The letter described the problem and provided recommendations for clinical use found in the instructions for use.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 26025 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
- Date initiated
- 2021-07-21
- Date posted
- 2021-09-15
- Date terminated
- 2024-09-09
- Location
- Miami Lakes, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS (K992347) | Cordis Corp. | 1999-10-08 |