# FDA recall Z-3106-2017

> **Spectranetics Corporation** · Class I · device recall initiated 2017-08-07.

## Product

Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only.    Product Usage:  It is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.

## Reason for recall

Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.

## Distribution

Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Poland, South Africa, Sweden, Switzerland, and United Kingdom.

## Key facts

- **Recall number:** Z-3106-2017
- **Recalling firm:** Spectranetics Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-07
- **Report date:** 2017-10-04
- **Termination date:** 2020-04-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Colorado Springs, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3106-2017

## Citation

> AI Analytics. FDA recall Z-3106-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3106-2017. Source: US FDA. Licensed CC0.

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