Recall Z-2432-2021— Cordis Corporation
Class I · Terminated
Class I FDA medical device recall by Cordis Corporation, initiated 2021-07-21, terminated 2024-09-09. It names one FDA 510(k) clearance: K992347. Product: Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C. Reason: 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..
- Recalling firm
- Cordis Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-07-21
- Terminated
- 2024-09-09
- Firm location
- Miami Lakes, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.