Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment — Class II medical device recall Z-1232-2017
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2017-03-01. Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan" Stabilizers and Tit
| Recall number | Z-1232-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Elkton, MD, United States |
| Recall initiated | 2015-01-05 |
| Classified | 2017-02-22 |
| Reported by FDA | 2017-03-01 |
| Terminated | 2017-02-23 |
| Countries outside the US | CA |
| Quantity | 1,463 |
| Reason classes | device malfunction |
| Lot numbers | 020R, 024R, 026R, 029R, 030R, 034R, 035R, 037R, 040, 048R, 052R |
| Model numbers | 401-231, 401-231U |
Product
Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
Reason for recall
Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan" Stabilizers and Titan" 360 Stabilizers because the Suction Tubing Clip may break when it is being attached to a Terumo CVS Hercules Stabilizing Arm. Although the clip is for convenience purposes and is not required for device operation, there is a potential for broken Suction Tubing Clip fragments to fall into the surgical site.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1232-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.