St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm
FDA device recall Z-1220-2019 · posted 2019-04-25 · Terminated
Recall details
- Recalling firm
- Abbott
- Reason for recall
- The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
- Action taken
- Abbott sent an Important Medical Device Correction letter dated November 20, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. Should you have questions about this issue, contact your local Abbott Representative or Abbott Support at 1-800-727-7846 (Opt3) (U.S.), 8:30am - 5:30pm Central Time Monday thru Friday.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MXC
- Quantity affected
- 32 devices
- Distribution
- US Nationwide Distribution in the states of AZ, CA, CO, ID, IL, LA, MA, MI, MO, NE, NH, NJ, NY, TN, TX, and WI.
- Date initiated
- 2018-11-19
- Date posted
- 2019-04-25
- Date terminated
- 2021-04-28
- Location
- Sylmar, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Confirm Rx Insertable Cardiac Monitor (ICM) System (K163407) | St. Jude Medical, Inc. | 2017-09-29 |