FDA Device recall Z-3213-2026
Pi-Cardia Inc
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of Pi-Cardia Inc by Pi Cardia, citing transfemoral catheter, positing arm may detached due to weld issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3213-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-06 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Pi Cardia |
| Distribution | US |
Product
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Reason
Transfemoral catheter, positing arm may detached due to weld issue.
Identifiers
| code_info | UDI-DI - (01)7290020101242 All serial numbers in the affected lot SCUS-00013: SC919, SC920, SC921, SC923, SC924, SC925,…UDI-DI - (01)7290020101242 All serial numbers in the affected lot SCUS-00013: SC919, SC920, SC921, SC923, SC924, SC925, SC926, SC927, SC928, SC929, SC930, SC931, SC932, SC933, SC934, SC935, SC936, SC937, SC938, SC939, SC940, SC941, SC942, SC943, SC944, SC945, SC946, SC947, SC948, SC949, SC950, SC951, SC952, SC953, SC954, SC956, SC957, SC958, SC960, SC961, SC962, SC963, SC964, SC966, SC967 and SC968. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3213-2026%22
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