Class II — Greatbatch Medical
| Recalling firm | GREATBATCH MEDICAL |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed. |
| Product | Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage. |
| Quantity | 11,360 |
| Distribution | CA |
| Initiated | 2017-02-15 |
| Classified | 2017-07-29 |
| Terminated | 2019-05-09 |
| Recall number | Z-2782-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Greatbatch Medical (Z-2782-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76514/
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