Gish Biomedical Inc The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product desgination VBCXGBS) consists of an extracorporeal heat exhanger and fluid administration set. The heat exchanger consists of a one piece, stainless steel bellows-configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the convolutions, and therefore improves heat exchange, minimizes priming v Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product desgination VBCXGBS) consists of an extracorporeal heat exhanger and fluid administration set. The heat exchanger consists of a one piece, stainless steel bellows-configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the convolutions, and therefore improves heat exchange, minimizes priming v
Brand
Gish Biomedical Inc
Lot Codes / Batch Numbers
315402, 307412, 336406, 010506, 067511, 080507, 171510, 220523, 336410, 005504, 031514, 087515, 143509, 157511, 199513, 234518, 262511, 0535818, 180501, 348420, 053515, 249512, 125515, 157527, 178525, 130500, 241500, 133500, 320408, 234515, 285417, 313418, 334408, 024507, 053510, 117501, 122508, 151509, 210510, 220526, 224519, 328415, 053511, 067515, 157509, 178520, 199510, 266509, 067518, 101520, 220530, 270503, 348400
Products Sold
315402, 307412, 336406, 010506, 067511, 080507, 171510, 220523, 336410, 005504, 031514, 087515, 143509, 157511, 199513, 234518, 262511, 0535818, 180501, 348420, 053515, 249512, 125515, 157527, 178525, 130500, 241500, 133500, 320408, 234515, 285417, 313418, 334408, 024507, 053510, 117501, 122508, 151509, 210510, 220526, 224519, 328415, 053511, 067515, 157509, 178520, 199510, 266509, 067518, 101520, 220530, 270503, 348400
Gish Biomedical Inc is recalling The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product due to The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks.
Recommended Action
Per FDA guidance
The firm faxed all initial consignees a letter notifying them of the recall and the affected lots involved. The consignee was instructed to immediately inspect their inventory, and if any units of the affected product remain, the consignee is to contact Gish Biomedical Customer Service at 866-221-9911. The consignee is to provide catalogue number, lot number and quantity and state the reason for replacement is the recall letter. Gish Customer Service, in conjunction with the sales representative and customer pack office, will work with the consignee in an effort to resolve inventory and configuration issues.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IN, MA, MI, NJ, NY
Page updated: Jan 10, 2026