Distal access catheters recalled after coating material lifting inside the lumen

Plain-English summary

The MEGA Ballast Distal Access Platform, model numbers MEGABT09180, MEGABT09190, MEGABT091100 and MEGABT091110, from Balt USA, is being recalled. The Mega Ballast 091 is a catheter with a semi-rigid proximal shaft and a highly flexible distal shaft, designed to be advanced through tortuous vasculature over a guidewire and dilator, with a hydrophilic coating from the tip to 40 cm proximal.

The recall follows an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter and lumen.

The recall covers 207 catheters distributed in Alabama, California, Colorado, Connecticut, Florida, Illinois, Kentucky, Massachusetts, New York, Tennessee, Texas and Utah. The FDA has classified the recall as Class I, its most serious category, which the agency uses where there is a reasonable probability of serious injury or death.

Facilities should quarantine affected stock immediately and follow Balt USA's instructions.

The recalled product

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 flex

Manufacturer

BALT USA, LLC

Category

Medical Device — Catheter

Hazard

• manufacturing-defect
• coating-delamination
• class-i
• neurovascular

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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