CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report
Pi-Cardia Inc. ShortCut REF: Z-a-20.003-US recalled
PI Cardia is recalling Pi-Cardia Inc. ShortCut REF: Z-a-20.003-US, distributed nationwide in the US. The recall was initiated on 6 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3213-2026
- FDA event ID
- 99664
- Recalling firm
- PI Cardia, Rehovot, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Jul 2026
- FDA classified
- 17 Sep 2026
- Reported
- 23 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 6 Jul 2026 | Recall initiated by company | |
| 17 Sep 2026 | Classified by FDA | +73 days |
| 23 Sep 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Transfemoral catheter, positing arm may detached due to weld issue.
Product as listed by the FDA
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Where it was distributed
US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
Nationwide CaliforniaDelawareKansasMassachusettsNew HampshireNew YorkPennsylvaniaUtah
Questions about this recall
Why was it recalled?
Transfemoral catheter, positing arm may detached due to weld issue.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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