Recalls / —
—#189719
Product
Cardioblate CryoFlex Surgical Ablation Console
- FDA product code
- OCL — Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K123733
- Affected lot / code info
- 1) Model 65CS1: Serial 10047 (GTIN 00763000014988) Serial 10048 (GTIN 00763000014988) Serial 10050 (GTIN 00763000014988) Serial 1689 (GTIN 00643169183834) Serial CSC-591 (GTIN 00613994867315) Serial CSC055 (GTIN 00613994867315) Serial 10051 (GTIN 00763000014988) 2) Model R65CS1: Serial RCSC-201 (GTIN 00613994981516)
Why it was recalled
There is potential for intermittent electrical connectivity between the console and probe.
Root cause (FDA determination)
Process control
Action the firm took
In the United States (US), beginning 27-SEP-2021 Medtronic initiated communications of an Urgent Medical Device Correction letter via 2-day UPS delivery to consignees who have received affected product according to Medtronic records. Outside of the United States (OUS), beginning 27-SEP-2021, a written Urgent Medical Device Correction letter is being delivered via regionally approved methods to consignees who have received affected product according to Medtronic records. Consignees are asked to review the Medtronic Urgent Medical Device Correction notification and follow the Recommended Actions, including quarantining affected Cardioblate CryoFlex Surgical Ablation Consoles in their inventory for servicing.
Recalling firm
- Firm
- Medtronic Perfusion Systems
- Address
- 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088
Distribution
- Distribution pattern
- Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea
Timeline
- Recall initiated
- 2021-09-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #189719. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.