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

Recall Z-2180-2017 — Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflatio

U.S. FDA — Device Enforcement · United States · 2017-04-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2180-2017
Date of alert: 2017-04-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Vascular Solutions, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 15075668

Reported risk: The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due to a potential defect in the sterile barrier. Use of affected product could pose a risk of microbial contamination, leading to infection.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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