Arrow International Inc: Medical Device Recall in 2019 - (Recall #: Z-0715-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130

Product Classification:

Class II

Date Initiated: November 15, 2019

Date Posted: December 25, 2019

Recall Number: Z-0715-2020

Event ID: 84399

Reason for Recall:

Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death

Status: Terminated

Product Quantity: 71 units

Code Information:

Lot Number: 16F19H0089

Distribution Pattern:

U.S. Nationwide, Canada

Voluntary or Mandated:

Voluntary: Firm initiated