Dolphin Inflation Device — Class II medical device recall Z-2180-2017
Terminated recall by Vascular Solutions, Inc., reported 2017-06-07, distributed in CA, HI, LA, NV, OH, OK, OR, PR…. The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due to
| Recall number | Z-2180-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vascular Solutions, Inc., Maple Grove, MN, United States |
| Recall initiated | 2017-04-12 |
| Classified | 2017-05-31 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2018-04-11 |
| Distributed | CA, HI, LA, NV, OH, OK, OR, PR, SC, TN, TX, WA |
| Quantity | 4,110 |
| Reason classes | microbial contamination, sterility |
| Lot numbers | 15075668, 15075924, 15115426, 15125175, 16025324, 16035493, 16055261 |
| Model numbers | 0185NA |
Product
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 inflation device and large volume syringe (30 cc). The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device. Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device. All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2180-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.