Z-0188-2026Class I

Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180...

Name: Z-0188-2026 Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180...
Creator: Balt USA, Llc
Published: 2025-09-25
License: https://open.fda.gov/license/

Balt USA, LLC / initiated 2025-09-25 / Open, Classified / root cause: manufacturing process

FDA source

BALT USA, LLC began a recall of Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software... on 2025-09-25. FDA classified it as Class I and gives the reason as "Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0188-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-09-25
Posted: 2025-10-24
Recalling firm: Balt USA, LLC
Product: Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flexible distal shaft. The design facilitates the advancement of the Mega Ballast to access the tortuous vasculature over a guidewire and a respective dilator. The outer surface of the Mega Ballast is coated with a hydrophilic coating to facilitate lubricity from tip to 40 cm proximal. The proximal end of the Mega Ballast incorporates a Luer fitting hub for the attachment of accessories. The Mega Ballast is provided sterile, non-pyrogenic, and is intended for single use only. Component: Not a component
Product code: DQY Catheter, Percutaneous
Reason for recall: Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 09/18/2025, the firm sent via Priority Mail an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that, Balt USA has became aware of a situation where multiple Mega Ballast units failed the in-house QC final inspection due to the exterior coating material lifting. Further assessment found this coating also went inside of the ID and protruded from the inner surface of the catheter, which is not intended as part of the manufacturing process. Hospitals are instructed to: - Cease use of the affected product. - Inform hospital staff, such as safety officers, pharmacists, purchasing agent, head of neuroradiology and the neuroradiology staff, physicians including but not limited to endovascular neurosurgeons and interventional neurologists, as well as any other person if deemed necessary. - Identify and locate the Mega Ballast products concerned by this recall procedure. - Collect and put in quarantine the Mega Ballast products concerned by this recall, then return them to Balt USA through the usual administrative returns procedure by contacting Balt USA s Customer Service department. Distributors are instructed to: - Cease processing of the affected recall product. - Inform customers about this notice. - Identify and locate the Mega Ballast products concerned by this recall procedure. - Collect and put in quarantine the Mega Ballast products concerned by this recall procedure and then return them to your local distributor as per their return procedure. For questions or further assistance: Contact: Quality Department Email: [email protected] Balt USA, LLC 29 Parker Suite 100 | Irvine CA, 92618 | USA Telephone: +949.788.1443 | Fax: +949.788.1444
Quantity in commerce: 207 catheters
Distribution: US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT.
Product codes and lots: Model Numbers and UDI-DI codes: Model No MEGABT09180 (00840303711780) Model No MEGABT09190 (00840303711797) Model No MEGABT091100 (00840303711803) Model No MEGABT091110 (00840303711810) Lot Numbers: F250600687, F250600686, F250600685, F250600455, F250600346, F250600345, F250600010, F250501434, F250501346, F250501091, F250500824, F250400219, F250400024, F250301020, F250300297, F250100956

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0188-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0188-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-24

Product code DQY

K242376Class IINext Generation Access PlatformBalt USA, LLC / cleared 2024-12-30

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)