Home › MEDTRONIC, INC. › NA
NA
MEDTRONIC, INC. · Model 6177 · UDI-DI 00763000842536
0
510(k) clearances
24,159
Adverse events (14 deaths)
11
Recalls
22
Facilities
Description
COVER 6177 PACK STERILE SLEEVE GLOBAL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-17 | Medtronic, Inc. | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-u |
| 2025-06-17 | Medtronic, Inc. | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-u |
| 2016-09-29 | Sorin Group USA, Inc. | Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate. |
| 2016-09-29 | Sorin Group USA, Inc. | Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate. |
| 2010-07-22 | Boston Scientific CRM Corp | Exposure to a magnet (typically in a clinic/hospital environment) may cause a magnetic reed switch to become permanently stuck in a closed position in certain Boston Scientific CRT |
| 2010-03-15 | Boston Scientific CRM Corp | Boston Scientific Corporation has stopped shipment and is retrieving unimplanted devices from US hospital shelves of all its implantable cardioverter defibrillators (ICDs) and card |
| 2006-10-06 | St Jude Medical CRMD | St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporti |
| 2006-10-06 | St Jude Medical CRMD | St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporti |
| 2006-06-24 | Boston Scientific CRM Corp | Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion in the affected devices |
| 2005-06-17 | Guidant Corporation | Laboratory analysis of returned devices revealed that deterioration in a wire insulator within the lead connector block, in conjuction with other factors, resulted in an electrical |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.