Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3106-2017 — 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 s

U.S. FDA — Device Enforcement · United States · 2017-08-07 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3106-2017
Date of alert: 2017-08-07
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Spectranetics Corporation
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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