Imperative Care — Class I medical device recall Z-2577-2021
Completed recall by IMPERATIVE CARE INC, reported 2021-10-06, distributed nationwide. There is a potential for distal end of catheters to fracture and become detached.
| Recall number | Z-2577-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | IMPERATIVE CARE INC, Campbell, CA, United States |
| Recall initiated | 2021-08-13 |
| Classified | 2021-09-29 |
| Reported by FDA | 2021-10-06 |
| Distributed | Nationwide (US) |
| Quantity | 3,118 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00812212030191 |
| Lot numbers | F2026201, F2026802, F2028801, F2028901, F2029501, F2029701, F2030801, F2031101, F2032502, F2035301, F2100802, F2101301, F2104102, F2108101, F2108801, F2109601, F2109701, F2110601, F2111101, F2112001, F2112301, F2113004, V2014902 |
| Model numbers | 137, ICRC071137 |
Product
Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.
Reason for recall
There is a potential for distal end of catheters to fracture and become detached.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2577-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.