# FDA recall Z-2782-2017

> **Greatbatch Medical** · Class II · device recall initiated 2017-02-15.

## 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.

## Reason for recall

One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.

## Distribution

CA

## Key facts

- **Recall number:** Z-2782-2017
- **Recalling firm:** Greatbatch Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-02-15
- **Report date:** 2017-08-09
- **Termination date:** 2019-05-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2782-2017

## Citation

> AI Analytics. FDA recall Z-2782-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2782-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*