VC2Recalls & reported problems across all models

We found 2 models of VC2 by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Dec 20, 2021 and Dec 20, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

VC2 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1805-2024 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

Most reported VC2 problems

VC2 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VC2™ 93448C

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall1 report
• VC2™ 93438

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall0 reports

Recent VC2 adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2021Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS VC2 ATRIAL CAVAL VENOUS CANNULA, DURING DECANNULATION AFTER THE END OF EXTRACORPOREAL CIRCULATION THE END OF THE CANNULA INSERTED IN THE EAR OF THE RIGHT ATRIUM OF THE PATIENT'S HEART DISINTEGRATED INTO 2 PARTS. THE SURGEON MANAGED TO REMOVE THE PART THAT REMAINED IN THE PATIENT IMMEDIATELY, SO THERE WAS NO DAMAGE TO THE PATIENT. PATIENT STATUS AT THE TIME OF THIS REPORT IS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION: THE CUSTOMER DID NOT REQUIRE ADDITIONAL DEVICES TO REMOVE THE PARTS THAT HAD FALLEN INTO THE PATIENT. THE CANNULA DID NOT COME APART WHERE IT WAS TIED. THE CUSTOMER STATED THAT AN INSTRUMENT OR DEVICE WAS NOT HOLDING THE CANNULA, THE CANNULA WAS FIXED WITH A STANDARD TURNSTILE SUTURE. A 2-0, CARDIOXYL SUTURE WAS USED TO HOLD THE CANNULA. THE CUSTOMER STATED THAT THE CANNULA WAS BROKEN OUTSIDE THE FIXATION SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13042080 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls