Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage
[RECALL]Apr 19, 2019 · Auris Health · Monarch Platform · Surgical robots
Failure Mode
RECALL
Event Date
Apr 19, 2019
Primary Entity
Auris Health
Robotic Platform
Monarch Platform
Jurisdiction / Location
Surgical robots
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Auris Health recalled the Monarch Aspirating Biopsy Needle (REF MBR-000012) after reports of needle breakage. 158 units. Source: FDA Class 2 device recall Z-0025-2020, openFDA enforcement / accessdata.fda.gov.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=Auris&postdatefrom=01/01/2017&postdateto=12/31/2026&PAGENUM=100
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=Auris&postdatefrom=01/01/2017&postdateto=12/31/2026&PAGENUM=100
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Details
Incident Context & FAQ
What happened in Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage?
Auris Health recalled the Monarch Aspirating Biopsy Needle (REF MBR-000012) after reports of needle breakage. 158 units. Source: FDA Class 2 device recall Z-0025-2020, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on April 19, 2019 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage?
Monarch Platform by Auris Health is the recorded robot involved in this incident.
Has anyone responded to Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.