Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
This recall has been terminated (originally issued May 28, 2019).
- Company
- Terumo Medical Corporation
- Recall Initiated
- April 26, 2019
- Posted
- May 28, 2019
- Terminated
- September 22, 2020
- Recall Number
- Z-1376-2019
- Quantity
- 1481
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
Distribution
The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.
Lot / Code Info
Lot Codes: VG29 VH28 VK09 VM20 VN08 VP07 WM03 WM31 VG05 VG09 VG21 VK18 VL25 VM11 VN17 VN27 WM03 WM17
Root Cause
Device Design
Action Taken
Urgent Medical Device Recall letters dated 4/26/19 were sent to customers.
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