Edwards Miller Balloon Atrioseptostomy Catheter Recalled for Deflation Issues
Edwards Lifesciences is recalling Miller Balloon Atrioseptostomy Catheters due to difficulty deflating the balloon and reports of fragmentation or detachment.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a Class I medical device with reports of device failure (fragmentation/detachment) during a critical procedure, which meets the criteria for a Severe rating due to the risk of significant injury.
Plain-English summary
Edwards Lifesciences, LLC is recalling the Miller Balloon Atrioseptostomy Catheter (REF: 830515F). The recall involves 1,564 units distributed worldwide, including across the United States and numerous foreign countries. The affected lots are those with an expiry date within 15 months from March 1, 2019.
The recall was initiated because of difficulty with balloon deflation after deployment, as well as reports of balloon fragmentation or detachment. This device is a prescription-only medical product used in pediatric cardiology to enlarge interatrial openings for the palliation of congenital cardiac defects.
Healthcare providers and patients should contact Edwards Lifesciences for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an…
- Manufacturer
- Edwards Lifesciences, LLC
- Affected units
- 1,564
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 (1)
- All lots within 15 months expiry from 03/01/2019
Distribution
Part of a larger recall action
This product is one of 2 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Edwards Lifesciences, LLC
See all →- ModerateEdwards EVOQUE Tricuspid Delivery System Labeling Update for Valve Functionality
FDA (Devices) · 2026-05-20
- SevereFEM-FLEX II FEMII016A cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereOptisite OPTI16 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16
- SevereFEM-FLEX II femoral arterial cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereOptisite OPTI18 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16
Same hazard · device failure
See all →- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
Similar recalls
- SevereEdwards Lifesciences Recalls IntraClude Intra-Aortic Occlusion Devices Due to Balloon Rupture Risk
FDA (Devices) · 2019-06-19
- HighFogarty Thru-Lumen Embolectomy Catheter Recalled for Delayed Balloon Deflation
FDA (Devices) · 2023-11-15
- ModerateEdwards Lifesciences Recalls Fogarty Adherent Clot Catheters Due to Balloon Size Error
FDA (Devices) · 2017-09-06
- HighEdwards IntraClude Intra-Aortic Occlusion Device Recalled for Inter-Lumen Leak
FDA (Devices) · 2019-04-17
- SevereMedtronic Rashkind Balloon Septostomy Catheter Recall for Quality Failures
FDA (Devices) · 2020-10-28
- HighEdwards Lifesciences Crimpers Recalled for Potential Sterile Barrier Pouch Holes
FDA (Devices) · 2013-04-24