Z-2180-2017Class II

Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use...

Name: Z-2180-2017 Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use...
Creator: Vascular Solutions, Inc.
Published: 2017-04-12
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2017-04-12 / Terminated / root cause: packaging

FDA source

Vascular Solutions, Inc. began a recall of Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular... on 2017-04-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2180-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-12
Posted: 2017-05-31
Terminated: 2018-04-11
Recalling firm: Vascular Solutions LLC
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.
Product code: MAV Syringe, Balloon Inflation
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: Customers were sent a Vascular Solutions "Urgent Medical Device Removal letter" dated April 12, 2017. The letter described the problem and the product involved in the recall. Advised consignees to remove and secure all affected product and to complete and return the "VSI Account Inventory Form". For questions contact your local Vascular Solutions Sales Representative. For further questions, please call (763) 656-4300.
Quantity in commerce: 4,110
Distribution: US Distribution including PR and to the states of : LA, TN, CA, SC, OR, WA, OK, NV, HI, OH, TX.
Product codes and lots: Lot Numbers: 15075668, 15075924, 15115426, 15125175, 16025324, 16035493, 16055261.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2180-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2180-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-05-31

Product code MAV

K042449Class IIDolphin Inflation DeviceSedat S.A. / cleared 2005-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)