FDA Device recall Z-2738-2016
PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marke…
- FDA Device
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marke… by Terumo Medical, citing terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is poss….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2738-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-16 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Medical |
| Distribution | US |
Product
PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath
Reason
Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve.
Identifiers
| code_info | Please see Attachment 3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2019-07-31 · Terumo Medical - Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
FDA Device · Class II · 2019-07-31 · Terumo Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2738-2016%22
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