Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Ind
FDA device recall Z-0466-2014 · posted 2013-12-06 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular, LLC
- Reason for recall
- Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000, "Hemopro 1"
- Action taken
- Maquet Inc. sent an Urgent - Medical Device Recall (Removal) Immediate Action Required Letter dated October 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please examine your inventory immediately to determine if you have any of the affected VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System (HEMOPRO 1) VH-3000 with the lot number(s), as specified above. The VH-3000 catalog number and lot number are located on the package label. Please remove the affected VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System and place in a secure location. NOTE: VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System HEMOPRO 1 lot numbers not listed are not affected by this recall and should not be removed. HEMOPRO 2 is not affected by this recall. Your MAQUET Cardiovascular Sales Representative will contact you shortly to assist with the completion of the enclosed Acknowledgement Form (Fax Back Form), the return of any affected VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System HEMOPRO 1 product and arrange for necessary replacement. We apologize for any inconvenience this may cause. If you have any questions, please contact your local MAQUET Cardiovascular Sales Representative or MAQUET Customer Service at 1-888-880-2874, Monday through Friday, between the hours of 6:00 a.m. and 5:00 p.m. PST. Thank you for your cooperation and immediate assistance.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 12,259 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Brazil, Czech Republic, Denmark, France, Hong Kong, Italy, Middle East, Netherlands, Singapore, Switzerland, and the United Kingdom.
- Date initiated
- 2013-10-30
- Date posted
- 2013-12-06
- Date terminated
- 2015-04-24
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM (K101274) | Maquet Cardiovascular, LLC | 2010-06-11 |
| GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 (K052274) | Guidant Corporation | 2005-09-21 |