Recall Z-1201-2017— Terumo Cardiovascular Systems Corporation
Class II · Terminated
Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2014-08-20, terminated 2017-02-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel. Reason: Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing Arms because the two pins that hold the sleeve attached to the distal end of the device may come loose, causing the pins and sleeve to separate from the device. While the arm can still function without the pins and sleeve in place, there is potential for the loose components to fall into the surgical site..
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-20
- Terminated
- 2017-02-15
- Firm location
- Elkton, MD, United States
Product description
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Reason for recall
Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing Arms because the two pins that hold the sleeve attached to the distal end of the device may come loose, causing the pins and sleeve to separate from the device. While the arm can still function without the pins and sleeve in place, there is potential for the loose components to fall into the surgical site.
Data sourced from openFDA. This site is unofficial and independent of the FDA.