VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo Cardiovascular System Indicated for us
FDA device recall Z-2854-2011 · posted 2011-07-21 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- Terumo Cardiovascular Systems received four (4) complaints from a single customer about tunnel breathing/inadequate insufflation with the VirtuoSaph Plus Endoscopic Vessel Harvesting System during cases in a limited production launch situation. Teumo's investigation identified issues with the devices's capability to maintain pressure within the tunnel.
- Action taken
- Terumo Cardiovascular Systems contacted the one customer to this device on June 10, 2010 by telephone. There was one consignee. The firm contacted this one consignee by phone on 6/10/2010. There were 2 contacts at this one consignee. The recalling firm contacted both of the contacts on 6/10/2010. The consignee was asked to dispose of remaking inventory of devices. The consignee said had disposed of the product. For information on this recall call (734) 741-6173
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 35 units
- Distribution
- Nationwide (USA) Distribution including the state of New York.
- Date initiated
- 2011-06-10
- Date posted
- 2011-07-21
- Date terminated
- 2011-07-27
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM (K092789) | Terumo Cardiovascular Systems Corp. | 2010-05-12 |