FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
- Recall number
- Z-0716-2020
- Recalling firm
- Arrow International Inc
- Product
- Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
- Status
- Terminated
- Initiated
- 2019-11-15
- Posted
- not on file
- Terminated
- 2020-06-19
- Reason
- 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
- Root cause
- Process control
- Action
- Arrow International issued letters on 11/15/19 stating reason for recall, health risk, and action to take: immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To acknowledge receipt of this Urgent Medical Device Recall Notice or to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1- 855-419-8507, Attn: Customer Service or ema il recalls@teleflex.com. your local sales representative or Customer Service at 1-866-396-2111. .
- Quantity
- 1 unit
- Distribution
- U.S. Nationwide, Canada
- Lot, serial or model codes
- Lot Number: 16F19H0093
- 510(k) numbers
- ["K892530"]
- PMA numbers
- not on file
- Product code
- DYG
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28