Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported November 5, 2025
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 hydrophil
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Balt USA, LLC recalled Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalo… - a critical-severity action.
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalo… was recalled by Balt USA, LLC in November 5, 2025. Reason: Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inn…. Check the official notice for the remedy. Verify recall #Z-0188-2026 with the FDA Devices before acting.
The recall
Balt USA, LLC issued this critical-severity FDA Devices recall-Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inn….
- Critical
- severity level
- Class I
- classification
- November 5, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0188-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0188-2026) was formally reported on November 5, 2025, with the manufacturer initiating the action on September 25, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Balt USA, LLC is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 207 catheters.
The documented reason for this recall is: Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen. Distribution data in the federal record shows the product reached: US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
207 catheters
Related Recalls
6
3 from same agency
Product description
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
Reason for recall
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0188-2026 |
| Date reported | November 5, 2025 |
| Date initiated | September 25, 2025 |
| Recalling firm | Balt USA, LLC |
| Firm location | Irvine, CA |
| Affected scope | 207 catheters |
| Distribution | US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0188-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Balt USA, LLC. Units affected: 207 catheters.
Why was this product recalled? ▼
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 5, 2025. Severity: Critical. Recall number: Z-0188-2026.
Where was the recalled product distributed? ▼
Distribution: US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0188-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 5, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.