The FDA announced on Aug. 13, 2021, that Imperative Care Inc. is recalling ZOOM 71 Reperfusion Catheters due to a potential for the distal end to fracture and detach, according to the FDA.
How to tell if you have it
- Brand: Imperative Care
- Product: ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm)
- UPC: 00812212030191
- Affected Lots: V2014902, F2026201, F2026802, F2028801, F2028901, F2029501, F2029701, F2030801, F2031101, F2035301, F2032502, F2100802, F2101301, F2104102, F2108101, F2108801, F2109601, F2109701, F2111101, F2110601, F2112301, F2113004, F2112001
- Units: 3118
The hazard
There is a potential for the distal end of the catheters to fracture and become detached, according to the FDA.
Context
GovInfoNow's records show other recent recalls of similar products include Penumbra RED 62 Reperfusion Catheter Recall (2026-07-24), Penumbra RED 68 Reperfusion Catheter Recall (2026-06-03), and Boston Scientific Imager II Angiographic Catheters Recall (2026-08-24).