Z-1201-2017Class II

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

Name: Z-1201-2017 Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Creator: Terumo Cardiovascular Systems Corporation
Published: 2014-08-20
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2014-08-20 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel on 2014-08-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1201-2017
Classification: Class II
Status: Terminated
Initiated: 2014-08-20
Posted: 2017-02-14
Terminated: 2017-02-15
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Product code: MWS Stabilizer, Heart
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.
Root cause tag: design
FDA root cause: Device Design
Action: Terumo Cardiovascular Systems has contact all affected parties (user facilities and consignees) via a Customer Notification Letter that advises of the recall activity.
Quantity in commerce: The total number of distributed devices stands at 260
Distribution: Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .
Product codes and lots: Serial Number Range 70194 through 70504

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1201-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1201-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-14

Product code MWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)