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U.S. Department of Health and Human Services

Class 2 Device Recall dolphin Inflation Device

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 Class 2 Device Recall dolphin Inflation Devicesee related information
Date Initiated by FirmApril 12, 2017
Create DateMay 31, 2017
Recall Status1 Terminated 3 on April 11, 2018
Recall NumberZ-2180-2017
Recall Event ID 77095
510(K)NumberK042449 
Product Classification Syringe, balloon inflation - Product Code MAV
ProductDolphin 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.
Code Information Lot Numbers: 15075668, 15075924, 15115426, 15125175, 16025324, 16035493, 16055261.
FEI Number 3002827704
Recalling Firm/
Manufacturer		 Vascular Solutions, Inc.
6464 Sycamore Ct N
Maple Grove MN 55369-6032
For Additional Information ContactSales representative
763-656-4300
Manufacturer 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.
FDA Determined
Cause 2		Packaging
ActionCustomers 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 Commerce4,110
DistributionUS Distribution including PR and to the states of : LA, TN, CA, SC, OR, WA, OK, NV, HI, OH, TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = MAV
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