Pinnacle¿ Destination¿ Peripheral Guiding Sheath — Class II medical device recall Z-1611-2013
Terminated recall by Terumo Medical Corporation, reported 2013-07-03, distributed nationwide. Medical devices were incorrectly labeled with extended expiration dates.
| Recall number | Z-1611-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Medical Corporation, Elkton, MD, United States |
| Recall initiated | 2013-05-30 |
| Classified | 2013-06-27 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2013-10-30 |
| Distributed | Nationwide (US) |
| Quantity | 20 units |
| Reason classes | labeling |
| Lot numbers | MM27 |
Product
Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.
Reason for recall
Medical devices were incorrectly labeled with extended expiration dates.
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-1611-2013. 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.