Reported Dec 29, 2021 · Ongoing
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Acclarent, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Acclarent, Inc. · 31 Technology Dr Suite 200 · Irvine, CA · 92618-2346
Is this the product you have?
- TruDi NAV Suction Instruments0-Degree
- REF
TDNS000Z70-Degree
- REF
TDNS070Zand 90-Degree
- REFTDNS090Z
- Lot codes and dates
- 0-Degree
- Lots
19031201903250190406019041801904240190503019050701906260190712019071701907220190724019072602003040200911020112402102080210309021042602105040210526021061002107070. 70-Degree
- Lots
190313719032571904067190501719050371905077190606719062671907127190813719081572003127. 90-Degree: 190313919032591904069190501919051391906079190826919092791909309191029920030292004029
- Amount recalled
- 1543
Where it was sold
Why it was recalled
Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve.
This product could cause temporary or reversible health problems — stop using it.
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