Recall record at a glance
| Official record | Z-1456-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Maquet Cardiovascular, LLC |
| Report date | Mar 22, 2017 |
| Recall initiation date | Jan 27, 2017 |
| Quantity | 4283 units |
| Location | Wayne, NJ, United States |
Official product description
VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.
Why the product was recalled
Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power.
Distribution information
US Nationwide Distribution
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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