Events

Recall of Device Recall Synovis VASCUGUARD Peripheral Vascular Patch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74625
  • Event Risk Class
    Class 2
  • Event Number
    Z-2533-2016
  • Event Initiated Date
    2016-06-24
  • Event Date Posted
    2016-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148062
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
  • Reason
    Baxter is issuing a safety alert in response to postmarketing reports received for the vasc u-guard peripheral vascular patch. baxter has received reports for intraoperative or postoperative bleeding episodes, which required additional clinical intervention. one report involved a case with a fatal outcome. update 9/1/2016 baxter issued a notice retrieving 6 lots of vascu-guard due to the increased postmarketing reports related to intraoperative and postoperative bleeding.
  • Action
    Baxter sent a Safety Alert to customers via USPS overnight delivery beginning 6/24/2016. The letter told of the reported adverse events, asked for product that product immediately be discontinued from use, to segregate/quarantine all affected lots, and to return the enclosed customer reply form. General questions regarding the Safety Alert should be directed to Baxter Product Surveillance at 1-800-437-5176, between 8:00 am - 5:00 pm Central Time Monday thru Friday. Clinical inquiries can be directed to Baxter's Medical information at 1-800-933-0303, Monday thru Friday 8:00 am - 5:00 pm central time. UPDATE 9/1/2016 Baxter issued an Urgent Product Recall letter beginning 9/1/2016. This letter explained the issue and identified affected product that was to be removed from the consignee and returned to Baxter. Customer is to contact Baxter Healthcare Center for Service to arrange for return and credit. This can be done at 888-229-0001 Monday thru Friday 7:00 am - 6:00 pm Central Time. General questions regarding the recall can be addressed to Baxter Product Surveillance at 800-437-5179 Monday thru Friday, 8:00 am - 5:00 pm Central Time.

Device

Device Recall Synovis VASCUGUARD Peripheral Vascular Patch
  • Model / Serial
    Product Code VG0106N, Lot #: SP16A04-1108933, SP16A11-1111696, SP16A12-1111933, SP16A12-1111938, SP16A12-1111942, SP16A12-1111947, SP16A27-1116312, SP16A29-1116884, SP16B04-1118465, SP16B08-1119650, SP16B12-1121361, SP16B22-1123979, SP16B24-1124658, SP16C01-1126439, SP16C01-1126508, SP16C07-1128790, SP16C08-1129067, SP16C09-1129905, SP16C10-1130129, SP16C10-1130134, SP16C23-1134739, SP16C28-1136324, SP16C28-1136332, SP16D06-1139370, SP16D13-1141301, SP16D19-1142941, SP16D20-1143649, SP16D20-1143655, SP16D21-1143852, SP16D28-1146476, SP16E04-1148533, SP16E04-1148534, SP16E19-1152299, SP16E24-1153675, SP16F01-1155425, SP16F01-1155678, SP16F01-1155682, SP16F01-1155685.   Product Code VG0108N, Lot #: SP16A04-1108941, SP16A04-1108956, SP16A04-1108974, SP16A06-1110391, SP16A12-1111872, SP16A12-1111952, SP16A14-1112703, SP16A14-1112720, SP16A18-1113372, SP16A19-1114051, SP16A19-1114056, SP16A21-1114800, SP16A21-1114802, SP16A21-1114805, SP16B04-1118471, SP16B04-1118475, SP16B05-1119212, SP16B05-1119217, SP16B08-1119654, SP16B08-1119720, SP16B12-1121365, SP16B12-1121366, SP16B19-1123365, SP16B22-1123983, SP16B25-1125254, SP16B25-1125260, SP16B25-1125268, SP16C01-1126459, SP16C07-1128755, SP16C08-1129301, SP16C10-1130184, SP16C10-1130191, SP16C10-1130200, SP16C10-1130208, SP16C10-1130219, SP16C10-1130227, SP16C16-1132096, SP16C18-1133115, SP16C18-1133138, SP16C18-1133148, SP16C18-1133152, SP16C18-1133155, SP16C18-1133157, SP16C21-1133807, SP16C22-1134481, SP16C24-1135156, SP16C28-1136307, SP16C28-1136436, SP16D01-1137764, SP16D04-1138414, SP16D04-1138417, SP16D12-1140707, SP16D12-1140708, SP16D19-1142958, SP16D19-1142967, SP16D21-1143872, SP16D21-1143878, SP16D28-1146462, SP16D28-1146466, SP16D28-1146471, SP16E04-1148520, SP16E04-1148522, SP16E04-1148549, SP16E05-1148667, SP16E11-1150104, SP16E11-1150110, SP16E11-1150115, SP16E11-1150174, SP16E19-1152326, SP16E19-1152330, SP16E19-1152335, SP16E24-1153278, SP16E24-1153280, SP16E26-1154142, SP16E26-1154146, SP16E27-1154532, SP16E27-1154534, SP16F01-1155407, SP16F07-1157497, SP16F07-1157505, SP16F07-1157513.   Product Code VG0110N, Lot #: SP16A12-1111926, SP16A12-1111931, SP16A20-1114346, SP16B22-1123992, SP16C08-1129312, SP16C08-1129329, SP16C09-1129911, SP16C25-1135841, SP16D11-1140274, SP16D11-1140284, SP16D20-1143641, SP16D20-1143643, SP16D25-1144838, SP16E11-1150202, SP16F07-1157244, SP16F07-1157253, SP16F07-1157260.   Product Code VG0209N, Lot #: SP16A04-1108918, SP16A12-1112283, SP16A12-1112284, SP16A20-1114352, SP16A21-1114790, SP16B15-1121467, SP16B22-1124000, SP16B25-1125139, SP16C08-1129339, SP16C08-1129346, SP16C14-1131192, SP16C16-1132144, SP16D01-1137778, SP16D11-1140290, SP16D18-1142652, SP16D20-1143633, SP16D20-1143638, SP16D28-1146487, SP16D28-1146606, SP16E04-1148530, SP16E11-1150205, SP16E19-1152309, SP16E27-1154668, SP16E27-1154693, SP16F08-1157871.   UPDATE 9/1/2016 the following lots are being retrieved for return to Baxter: Product Code VG0106N: Lot #: SP16C09-1129905. Product Code VG0108N: Lot #: SP16B08-1119720, SP16C18-1133152, SP16D04-1138417, SP16D28-1146462, SP16E04-1148522.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide including Puerto Rico, and outside the US to include: Australia, Austria, Finland, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Poland, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, United Kingdom.
  • Product Description
    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: || 1 cm x 6 cm, product code VG0106N, || 0.8 cm x 8 cm, product code VG0108N, || 1 cm x 10 cm, product code VG0110N, and || 2 cm x 9 cm, product code VG0209N. || VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. || UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: || 1 cm x 6 cm, product code VG0106N, || 0.8 cm x 8 cm, product code VG0108N.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA