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Recall Observatory FDA recall evidence

Device 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.

Z-2577-2021

August 13, 2021

Class I

Product summary

Firm
IMPERATIVE CARE INC
Event
Event 88611
Status
Completed
Classification
Class I
Quantity
3118 units
Official record key
device-enforcement:Z-2577-2021

Official wording

Reason: There is a potential for distal end of catheters to fracture and become detached.

Code information: 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

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for distal end of catheters to fracture and become detached.