—#152881

Product

Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel

FDA product code: MWS — Stabilizer, Heart
Device class: Class 1
Medical specialty: Cardiovascular
Affected lot / code info: Serial Number Range 70194 through 70504

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

Terumo Cardiovascular Systems has contact all affected parties (user facilities and consignees) via a Customer Notification Letter that advises of the recall activity.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 125 Blue Ball Rd, Elkton, Maryland 21921-5315

Distribution

Distribution pattern: Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .

Timeline

Recall initiated: 2014-08-20
Posted by FDA: 2017-02-14
Terminated: 2017-02-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152881. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.