Vascular Solutions Recalls Dolphin Inflation Devices Due to Sterile Barrier Defect
Vascular Solutions, Inc. is recalling 4,110 Dolphin Inflation Devices due to a potential sterile barrier defect that could lead to microbial contamination and infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (infection from microbial contamination) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Vascular Solutions, Inc. is recalling 4,110 units of the Dolphin Inflation Device (REF 0185NA) due to a potential defect in the sterile barrier. The device is a single-use, sterile inflation tool used in cardiovascular procedures to pressurize and depressurize balloon catheters. The recall was initiated by the manufacturer, Perouse Medical.
The affected products were distributed in the United States, including Puerto Rico, and specifically to the states of Louisiana, Tennessee, California, South Carolina, Oregon, Washington, Oklahoma, Nevada, Hawaii, Ohio, and Texas. The recall covers specific lot numbers: 15075668, 15075924, 15115426, 15125175, 16025324, 16035493, and 16055261.
Use of the affected devices could pose a risk of microbial contamination, which may lead to infection. Healthcare providers and facilities should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- 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…
- Manufacturer
- Vascular Solutions, Inc.
- Category
- Medical Device — Cardiovascular
- Affected units
- 4,110
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot Numbers: 15075668
- 15075924
- 15115426
- 15125175
- 16025324
- 16035493
- 16055261.
Distribution
Related recalls
Same manufacturer · Vascular Solutions, Inc.
See all →- SevereVascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation
FDA (Devices) · 2020-10-28
- SevereVascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation
FDA (Devices) · 2020-10-28
- SevereVascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation
FDA (Devices) · 2020-10-28
- SevereVascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk
FDA (Devices) · 2020-10-28
- SevereVascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk
FDA (Devices) · 2020-05-06
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- SevereDeRoyal Dolphin Inflation Device Recalled for Sterility Assurance Defect
FDA (Devices) · 2017-07-05
- ModeratePerouse Medical Recalls Dolphin Inflation Devices Due to Broken Blister
FDA (Devices) · 2017-05-10
- HighIntelliSystem Inflation Device from Merit Medical Recalled for Sterile Barrier Defect
FDA (Devices) · 2024-10-23
- HighMonarch Inflation Devices Recalled for Sterile Barrier Defects
FDA (Devices) · 2024-10-23
- HighMonarch Inflation Device Recalled Due to Sterile Barrier Manufacturing Defect
FDA (Devices) · 2024-10-23
- HighDiamondTOUCH Digital Inflation Device Sterile Barrier Defect Recall
FDA (Devices) · 2024-10-23