Ellipse VR recall
ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
Why was Ellipse VR recalled?
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Number: 1281828, 1281840, 1282688, 1282724, 1282734, 1283113, 1283627, 1283633, 1283634, 1283639, 1283641, 1283643, 1283646, 1283648, 1283656, 1283657, 1283659, 1283660, 1283672, 1283680, 1283681, 1283683, 1283689, 1283690, 1283692, 1283695, 1283697, 1283703, 1283704, 1283708, 1283742, 1283747, 1283749, 1283766, 1283772, 1283780, 1283783, 1283784, 1283788, 1283832, 1283838, 1283845, 1283868, 1283884, 9831441, 9831445, 9831759
- Product
- ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
- Recalling firm
- St Jude Medical Inc.
- Quantity
- 47
- Distribution
- Worldwide distribution. US nationwide, and countries: DE, FR, IT, ES, NL, PT, SE, HU, DK, PL, IL, GP, DZ, CH, SA, SK, LU, NZ, VN, and NO
- Recall date
- August 14, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)