Bipolar cord for use with the VirtuoSaph Endoscopic Vein Harvesting System, MCBICORD1, Terumo Cardiovascular System, Ann
FDA device recall Z-1230-2011 · posted 2011-02-14 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- The Bipolar cord product specification indicates the product has a service life of 50 uses. However the IFU does not specify an end of service life. The firm has recieved 46 complaints on the Bipolar cord. The firm investigated and found that the units involved in the complaints were often over 12 months old. The firm believes the units involved in the complaints were beyond their product life
- Action taken
- Terumo Cardiovascular Systems Corporation sent an URGENT MEDICAL DEVICE CORRECTION letter dated January 10, 2011, to Operating room managers. The letter informed the customers of the Bipolar cord product life of 50 uses. The letter states that the IFU for the bipolar cord is being updated to include the information regarding the limit of 50 uses and sterlization cycles. The letter recommends that user keep a sterile back up bi-polar cord in a convienent place during endoscopic vein harvesting procedures. The firm provided a tracking sheet in each package to help users track the number of sterlization cycles for the cord. Customers were instructed to review the Medical Device Correction notice, assure that all users were aware of the notice, and confirm receipt of the communicaiton by faxing the attached Customer Response Form to the fax number indicated on the form. For questions regarding this recall call Terumo CVS Customer Service at 1-800-521-2818.
- Root cause
- Other
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 2782 cords
- Distribution
- Worldwide Distribution - United States including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, , NY, MO, MS, MT, NC, NE, NH, NJ, NM, OH, OK, OR, PA, SC, TN, TX, VA, WI, A
- Date initiated
- 2011-01-10
- Date posted
- 2011-02-14
- Date terminated
- 2011-07-13
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550 (K083194) | Terumo Cardiovascular Systems Corp. | 2009-01-16 |