FDA Device recall Z-0716-2020
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
- FDA Device
- Class II
- terminated
- Published 2019-12-25
On 2019-12-25 the FDA classified a Class II recall of Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J by Arrow International, citing 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 slow….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0716-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-15 |
| Published | 2019-12-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Arrow International |
| Distribution | US |
Product
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
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
Identifiers
| code_info | Lot Number: 16F19H0093 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Arrow International
- Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B
FDA Device · Class I · 2026-06-24 · Arrow International - Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC
FDA Device · Class I · 2026-06-24 · Arrow International
All Arrow International recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0716-2020%22
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